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Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00676403
Recruitment Status : Completed
First Posted : May 13, 2008
Results First Posted : February 4, 2010
Last Update Posted : July 7, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Restless Legs Syndrome
Interventions Drug: placebo
Drug: Pregabalin
Enrollment 137

Recruitment Details  
Pre-assignment Details Subjects meeting entry criteria with a confirmed diagnosis of Restless Leg Syndrome completed a washout of medications if needed prior to starting a 7-day single-blind placebo run-in to identify and exclude placebo responders and to adapt subjects to take study drug 1-3 hours prior to bedtime. Of 218 subjects screened, 137 subjects entered.
Arm/Group Title Placebo Pregabalin 50 mg Pregabalin 100 mg Pregabalin 150 mg Pregabalin 300 mg Pregabalin 450 mg
Hide Arm/Group Description Single daily oral dose. Single daily 50 mg oral dose. Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3. Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3. Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7). Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
Period Title: Overall Study
Started 23 22 23 22 24 23
Completed 21 20 22 17 23 18
Not Completed 2 2 1 5 1 5
Reason Not Completed
Adverse Event             1             2             0             5             1             2
Lost to Follow-up             0             0             0             0             0             1
Reason Unspecified             1             0             1             0             0             1
Withdrawal by Subject             0             0             0             0             0             1
Arm/Group Title Placebo Pregabalin 50 mg Pregabalin 100 mg Pregabalin 150 mg Pregabalin 300 mg Pregabalin 450 mg Total
Hide Arm/Group Description Single daily oral dose. Single daily 50 mg oral dose. Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3. Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3. Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7). Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11). Total of all reporting groups
Overall Number of Baseline Participants 23 22 23 22 24 23 137
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 23 participants 22 participants 24 participants 23 participants 137 participants
18 - 44 years 4 5 7 2 9 3 30
45 - 64 years 19 15 16 20 15 19 104
>=65 years 0 2 0 0 0 1 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 23 participants 22 participants 24 participants 23 participants 137 participants
Female
13
  56.5%
13
  59.1%
16
  69.6%
13
  59.1%
19
  79.2%
16
  69.6%
90
  65.7%
Male
10
  43.5%
9
  40.9%
7
  30.4%
9
  40.9%
5
  20.8%
7
  30.4%
47
  34.3%
1.Primary Outcome
Title Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6
Hide Description IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and better quality of life. Change from baseline = score at observation minus score at baseline.
Time Frame Baseline, Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT. Baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit. Recall period = week prior to assessment.
Arm/Group Title Placebo Pregabalin 50 mg Pregabalin 100 mg Pregabalin 150 mg Pregabalin 300 mg Pregabalin 450 mg
Hide Arm/Group Description:
Single daily oral dose.
Single daily 50 mg oral dose.
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
Overall Number of Participants Analyzed 21 20 22 18 23 20
Least Squares Mean (Standard Error)
Unit of Measure: scores on scale
-7.73  (1.720) -11.83  (1.771) -11.76  (1.694) -16.02  (1.865) -12.89  (1.713) -16.26  (1.771)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg, Pregabalin 100 mg, Pregabalin 150 mg, Pregabalin 300 mg, Pregabalin 450 mg
Comments Dose response analysis ED 50: dose providing 50% of the maximal effect. Statistics were obtained from three parameter model Y = D + G*exp(B*dose) by bootstrapping 2000 data sets, where D = expected response of saturation (maximal effect), B = related to slope of the dose response mechanism (change in response relative to the change in dose), and D+G = expected response at zero dose.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ED-50: Bootstrap Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 37.3
Confidence Interval 95%
0.1 to 157.7
Estimation Comments Non-convergence for the non-liner model occurred in some bootstrap samples which were not included in summarizing the ED50 distribution or confidence interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg, Pregabalin 100 mg, Pregabalin 150 mg, Pregabalin 300 mg, Pregabalin 450 mg
Comments Dose response analysis ED 90: dose providing 90% of the maximal effect. Statistics were obtained from three parameter model Y = D + G*exp(B*dose) by bootstrapping 2000 data sets, where D = expected response of saturation (maximal effect), B = related to slope of the dose response mechanism (change in response relative to the change in dose), and D+G = expected response at zero dose.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ED 90: Bootstrap Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 123.9
Confidence Interval 95%
0.4 to 523.9
Estimation Comments Non-convergence for the non-liner model occurred in some bootstrap samples which were not included in summarizing the ED90 distribution or confidence interval.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0983
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.10
Confidence Interval 95%
-8.97 to 0.77
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.472
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0966
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.03
Confidence Interval 95%
-8.78 to 0.73
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.415
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.29
Confidence Interval 95%
-13.31 to -3.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.548
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0353
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.16
Confidence Interval 95%
-9.96 to -0.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.437
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.53
Confidence Interval 95%
-13.40 to -3.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.469
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)
Hide Description Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 6 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.
Time Frame Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT; N=number of subjects in a treatment group; n=number of subjects with a clinical Global Impressions Improvement (CGI-I) rating.
Arm/Group Title Placebo Pregabalin 50 mg Pregabalin 100 mg Pregabalin 150 mg Pregabalin 300 mg Pregabalin 450 mg
Hide Arm/Group Description:
Single daily oral dose.
Single daily 50 mg oral dose.
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
Overall Number of Participants Analyzed 23 22 23 22 24 23
Measure Type: Number
Unit of Measure: participants
Week 6: Responders (n=21, 20, 22, 18, 23, 20) 13 12 15 11 17 18
Week 6: Non-Responders 8 8 7 7 6 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8784
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6767
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8955
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9505
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0466
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Hide Description CGI-S Scale: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
Time Frame Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT; N=number of subjects in a treatment group. LOCF: Last Observation Carried Forward.
Arm/Group Title Placebo Pregabalin 50 mg Pregabalin 100 mg Pregabalin 150 mg Pregabalin 300 mg Pregabalin 450 mg
Hide Arm/Group Description:
Single daily oral dose.
Single daily 50 mg oral dose.
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
Overall Number of Participants Analyzed 23 22 23 22 24 23
Measure Type: Number
Unit of Measure: participants
Baseline: Normal, Not at All Ill 0 0 0 0 0 0
Baseline: Borderline, Mentally Ill 0 0 0 0 0 0
Baseline: Mildly Ill 1 1 2 4 2 2
Baseline: Moderately Ill 6 9 8 5 11 6
Baseline: Markedly Ill 7 8 7 5 3 5
Baseline: Severely Ill 8 3 6 7 8 10
Baseline: Among the Most Extremely Ill 1 1 0 1 0 0
Week 1: Normal, Not at All Ill 1 1 1 1 0 3
Week 1: Borderline, Mentally Ill 0 1 1 1 4 2
Week 1: Mildly Ill 4 6 5 8 5 7
Week 1: Moderately Ill 10 8 5 7 6 8
Week 1: Markedly Ill 4 3 5 1 3 2
Week 1: Severely Ill 4 2 3 2 5 1
Week 1: Among the Most Extremely Ill 0 0 0 0 0 0
Week 2: Normal, Not at All Ill 0 2 1 2 3 7
Week 2: Borderline, Mentally Ill 3 4 2 3 6 2
Week 2: Mildly Ill 10 5 9 7 4 8
Week 2: Moderately Ill 3 5 5 6 5 3
Week 2: Markedly Ill 3 3 4 0 3 0
Week 2: Severely Ill 3 1 1 1 1 0
Week 2: Among the Most Extremely Ill 1 0 0 0 0 0
Week 4: Normal, Not at All Ill 1 2 2 5 4 8
Week 4: Borderline, Mentally Ill 4 2 2 2 6 5
Week 4: Mildly Ill 8 7 11 5 4 4
Week 4: Moderately Ill 4 6 6 5 5 2
Week 4: Markedly Ill 3 2 1 1 2 1
Week 4: Severely Ill 2 2 1 1 2 0
Week 4: Among the Most Extremely Ill 0 0 0 0 0 0
Week 6: Normal, Not at All Ill 1 3 4 4 6 7
Week 6: Borderline, Mentally Ill 3 3 4 4 4 5
Week 6: Mildly Ill 11 6 7 7 7 6
Week 6: Moderately Ill 2 5 5 3 1 1
Week 6: Markedly Ill 2 2 2 0 4 1
Week 6: Severely Ill 2 1 0 0 1 0
Week 6: Among the Most Extremely Ill 0 0 0 0 0 0
LOCF: Normal 1 3 4 4 6 7
LOCF: Borderline, Mentally Ill 3 3 4 4 4 6
LOCF: Mildly Ill 12 6 7 9 7 7
LOCF: Moderately Ill 2 6 5 5 1 1
LOCF: Markedly Ill 2 2 2 0 4 1
LOCF: Severely Ill 2 2 1 0 2 1
LOCF: Among the Most Extremely Ill 1 0 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3876
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7959
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2032
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7032
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0551
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4100
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6524
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3219
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3509
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0053
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9835
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6668
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2823
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5687
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0043
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8662
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3656
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0806
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5381
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0090
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9748
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3936
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1563
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6357
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0133
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline
Hide Description Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Latency subscale (time to fall asleep [in minutes]): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Lower score reflects greater ease (shorter time) in falling asleep. Change from baseline = score at observation minus score at baseline.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.
Arm/Group Title Placebo Pregabalin 50 mg Pregabalin 100 mg Pregabalin 150 mg Pregabalin 300 mg Pregabalin 450 mg
Hide Arm/Group Description:
Single daily oral dose.
Single daily 50 mg oral dose.
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
Overall Number of Participants Analyzed 23 22 23 22 24 23
Least Squares Mean (Standard Error)
Unit of Measure: minutes
Week 1 -9.8  (5.60) -16.3  (5.76) -13.2  (5.60) -10.4  (5.76) -9.1  (5.65) -20.2  (5.62)
Week 2 -8.9  (5.60) -20.7  (5.84) -17.2  (5.65) -16.3  (6.00) -13.0  (5.71) -34.3  (5.69)
Week 3 -14.6  (5.71) -18.9  (5.90) -13.1  (5.60) -17.8  (6.00) -17.8  (5.71) -33.7  (5.88)
Week 4 -13.6  (5.66) -20.4  (5.90) -20.4  (5.60) -18.2  (6.00) -18.2  (5.71) -37.1  (5.82)
Week 5 -15.9  (5.71) -26.8  (5.90) -17.6  (5.60) -24.0  (6.07) -13.4  (5.71) -36.1  (5.82)
Week 6 -12.4  (5.71) -25.4  (5.90) -19.5  (5.65) -25.1  (6.14) -10.1  (5.71) -34.9  (5.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4133
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.6
Confidence Interval 95%
-22.4 to 9.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 1: Conrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6676
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.4
Confidence Interval 95%
-19.0 to 12.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.92
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9355
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval 95%
-16.5 to 15.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.04
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9355
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.6
Confidence Interval 95%
-15.1 to 16.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.97
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1895
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.5
Confidence Interval 95%
-26.1 to 5.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.94
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1443
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.9
Confidence Interval 95%
-27.8 to 4.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.10
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2946
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.4
Confidence Interval 95%
-24.0 to 7.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.96
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3686
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.4
Confidence Interval 95%
-23.6 to 8.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.22
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6079
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.1
Confidence Interval 95%
-19.9 to 11.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.02
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -25.5
Confidence Interval 95%
-41.2 to -9.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.99
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5976
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.3
Confidence Interval 95%
-20.5 to 11.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.22
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8527
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.5
Confidence Interval 95%
-14.3 to 17.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.00
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6973
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.2
Confidence Interval 95%
-19.6 to 13.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.29
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6895
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.2
Confidence Interval 95%
-19.2 to 12.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.09
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0209
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.1
Confidence Interval 95%
-35.2 to -2.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.21
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4084
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.8
Confidence Interval 95%
-22.9 to 9.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.18
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3958
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.8
Confidence Interval 95%
-22.5 to 8.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.96
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5776
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.6
Confidence Interval 95%
-20.9 to 11.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.25
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5665
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.6
Confidence Interval 95%
-20.5 to 11.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.06
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0041
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -23.5
Confidence Interval 95%
-39.6 to -7.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.13
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1842
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.9
Confidence Interval 95%
-27.1 to 5.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.22
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8269
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.8
Confidence Interval 95%
-17.5 to 14.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.00
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3319
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.1
Confidence Interval 95%
-24.5 to 8.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.34
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7552
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.5
Confidence Interval 95%
-13.4 to 18.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.09
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0137
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -20.3
Confidence Interval 95%
-36.3 to -4.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.16
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1157
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.0
Confidence Interval 95%
-29.2 to 3.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.22
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3791
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.1
Confidence Interval 95%
-22.9 to 8.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.04
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1329
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.7
Confidence Interval 95%
-29.2 to 3.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.39
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7723
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.3
Confidence Interval 95%
-13.6 to 18.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.09
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0063
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -22.5
Confidence Interval 95%
-38.6 to -6.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.16
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline
Hide Description Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Hours of sleep subscale reflects change in hours of sleep from baseline. Numerical rating completed by the subject 30 minutes after waking; recall period is the night before.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit.
Arm/Group Title Placebo Pregabalin 50 mg Pregabalin 100 mg Pregabalin 150 mg Pregabalin 300 mg Pregabalin 450 mg
Hide Arm/Group Description:
Single daily oral dose.
Single daily 50 mg oral dose.
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
Overall Number of Participants Analyzed 23 22 23 22 24 23
Least Squares Mean (Standard Error)
Unit of Measure: hours
Week 1 0.23  (0.177) 0.57  (0.183) 0.29  (0.177) 0.55  (0.182) 0.45  (0.177) 0.72  (0.178)
Week 2 0.36  (0.177) 0.65  (0.186) 0.52  (0.179) 0.81  (0.192) 0.76  (0.180) 1.07  (0.181)
Week 3 0.36  (0.182) 0.61  (0.188) 0.53  (0.177) 0.89  (0.192) 0.72  (0.180) 1.32  (0.189)
Week 4 0.27  (0.180) 0.81  (0.188) 0.46  (0.177) 0.93  (0.192) 0.65  (0.180) 1.03  (0.187)
Week 5 0.37  (0.182) 1.03  (0.188) 0.43  (0.177) 0.97  (0.195) 0.61  (0.180) 1.43  (0.187)
Week 6 0.19  (0.182) 0.84  (0.188) 0.42  (0.179) 0.95  (0.198) 0.44  (0.180) 1.11  (0.187)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1715
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.35
Confidence Interval 95%
-0.15 to 0.85
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.254
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7944
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.07
Confidence Interval 95%
-0.43 to 0.56
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.251
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1994
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.33
Confidence Interval 95%
-0.17 to 0.83
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.255
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3652
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.23
Confidence Interval 95%
-0.27 to 0.72
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.251
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0481
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.50
Confidence Interval 95%
0.00 to 0.99
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.251
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2501
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval 95%
-0.21 to 0.80
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.256
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5191
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Confidence Interval 95%
-0.33 to 0.66
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.252
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0817
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.46
Confidence Interval 95%
-0.06 to 0.97
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.262
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1146
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.40
Confidence Interval 95%
-0.10 to 0.90
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.253
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0054
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.71
Confidence Interval 95%
0.21 to 1.21
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.253
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3389
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.25
Confidence Interval 95%
-0.26 to 0.76
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.261
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5079
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.17
Confidence Interval 95%
-0.33 to 0.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.254
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0453
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.53
Confidence Interval 95%
0.01 to 1.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.265
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1622
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.36
Confidence Interval 95%
-0.15 to 0.86
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.256
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.96
Confidence Interval 95%
0.45 to 1.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.262
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0383
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.54
Confidence Interval 95%
0.03 to 1.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.260
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4495
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.19
Confidence Interval 95%
-0.31 to 0.69
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.253
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0135
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.65
Confidence Interval 95%
0.14 to 1.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.263
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1423
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.37
Confidence Interval 95%
-0.13 to 0.87
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.254
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0035
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.76
Confidence Interval 95%
0.25 to 1.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.259
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0125
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.66
Confidence Interval 95%
0.14 to 1.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.261
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8021
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval 95%
-0.44 to 0.56
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.254
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0249
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.60
Confidence Interval 95%
0.08 to 1.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.267
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3383
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.25
Confidence Interval 95%
-0.26 to 0.75
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.256
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.06
Confidence Interval 95%
0.55 to 1.57
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.260
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0133
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.65
Confidence Interval 95%
0.14 to 1.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.261
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3820
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.22
Confidence Interval 95%
-0.28 to 0.73
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.256
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0053
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.75
Confidence Interval 95%
0.23 to 1.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.269
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3258
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.25
Confidence Interval 95%
-0.25 to 0.76
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.256
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.92
Confidence Interval 95%
0.41 to 1.43
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.260
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline
Hide Description Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Number of awakenings subscale: numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Fewer awakenings reflect better quality of sleep. Change from baseline = score at observation minus score at baseline.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline in at least one post-baseline visit.
Arm/Group Title Placebo Pregabalin 50 mg Pregabalin 100 mg Pregabalin 150 mg Pregabalin 300 mg Pregabalin 450 mg
Hide Arm/Group Description:
Single daily oral dose.
Single daily 50 mg oral dose.
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
Overall Number of Participants Analyzed 23 22 23 22 24 23
Least Squares Mean (Standard Error)
Unit of Measure: awakenings
Week 1 -0.5  (0.21) -0.9  (0.21) -1.0  (0.21) -1.2  (0.21) -0.7  (0.21) -0.8  (0.21)
Week 2 -0.7  (0.21) -1.0  (0.22) -1.3  (0.21) -1.3  (0.23) -1.3  (0.21) -1.1  (0.21)
Week 3 -0.7  (0.21) -1.0  (0.22) -1.0  (0.21) -1.3  (0.23) -1.2  (0.21) -1.4  (0.22)
Week 4 -0.9  (0.21) -1.1  (0.22) -1.2  (0.21) -1.5  (0.23) -1.1  (0.21) -1.2  (0.22)
Week 5 -0.8  (0.21) -1.3  (0.22) -1.0  (0.21) -1.6  (0.23) -1.2  (0.21) -1.5  (0.22)
Week 6 -1.0  (0.21) -1.0  (0.22) -1.1  (0.21) -1.5  (0.23) -1.0  (0.21) -1.2  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1429
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval 95%
-1.0 to 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0547
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval 95%
-1.2 to 0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0095
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Confidence Interval 95%
-1.4 to -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3676
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval 95%
-0.9 to 0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2959
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval 95%
-0.9 to 0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3435
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval 95%
-0.9 to 0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0895
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Confidence Interval 95%
-1.1 to 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0844
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Confidence Interval 95%
-1.1 to 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0675
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Confidence Interval 95%
-1.1 to 0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2250
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval 95%
-1.0 to 0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3728
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval 95%
-0.9 to 0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2686
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval 95%
-0.9 to 0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0753
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval 95%
-1.2 to 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1335
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Confidence Interval 95%
-1.0 to 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0220
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval 95%
-1.3 to -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5754
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval 95%
-0.8 to 0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3480
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval 95%
-0.9 to 0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0554
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval 95%
-1.2 to 0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4362
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval 95%
-0.8 to 0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 450 mg
Comments Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3631
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval 95%
-0.9 to 0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 50 mg
Comments Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1152
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Confidence Interval 95%
-1.1 to 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 100 mg
Comments Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4741
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval 95%
-0.8 to 0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 150 mg
Comments Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0091
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Confidence Interval 95%
-1.4 to -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, Pregabalin 300 mg
Comments Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1721
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval 95%
-1.0 to 0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview