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

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ClinicalTrials.gov Identifier: NCT00676403

Recruitment Status : Completed

First Posted : May 13, 2008

Results First Posted : February 4, 2010

Last Update Posted : February 10, 2021

Sponsor:

Information provided by (Responsible Party):

Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

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

Participant Flow

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
Arm/Group Description	Single daily oral dose.	Single daily 50 mg oral dose.	Single daily 100 mg oral dose. Dose...	Single daily 150 mg oral dose. Dose...	Single daily 300 mg oral dose. Dose...	Single daily 450 mg oral dose. Dose...
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

Baseline Characteristics

Arm/Group Title		Placebo	Pregabalin 50 mg	Pregabalin 100 mg	Pregabalin 150 mg	Pregabalin 300 mg	Pregabalin 450 mg	Total
Arm/Group Description		Single daily oral dose.	Single daily 50 mg oral dose.	Single daily 100 mg oral dose. Dose...	Single daily 150 mg oral dose. Dose...	Single daily 300 mg oral dose. Dose...	Single daily 450 mg oral dose. Dose...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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%

Outcome Measures

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
Description	IRLS: Subject-rated instrument to assess RLS symptom severity and impa...
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

Outcome Measure Data

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
Arm/Group Description:	Single daily oral dose.	Single daily 50 mg oral dose.	Single daily 100 mg oral dose. Dose...	Single daily 150 mg oral dose. Dose...	Single daily 300 mg oral dose. Dose...	Single daily 450 mg oral dose. Dose...
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)

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 + Gexp(Bdose) 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 (legacy)
	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.

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 + Gexp(Bdose) 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 (legacy)
	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.

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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)
Description	Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinic...
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

Outcome Measure Data

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
Arm/Group Description:	Single daily oral dose.	Single daily 50 mg oral dose.	Single daily 100 mg oral dose. Dose...	Single daily 150 mg oral dose. Dose...	Single daily 300 mg oral dose. Dose...	Single daily 450 mg oral dose. Dose...
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

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.8784
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6767
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.8955
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.9505
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	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)
Description	CGI-S Scale: 7-point clinician rated scale to assess severity of subje...
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)

Outcome Measure Data

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
Arm/Group Description:	Single daily oral dose.	Single daily 50 mg oral dose.	Single daily 100 mg oral dose. Dose...	Single daily 150 mg oral dose. Dose...	Single daily 300 mg oral dose. Dose...	Single daily 450 mg oral dose. Dose...
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

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3876
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.7959
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.2032
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.7032
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0551
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.4100
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6524
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3219
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3509
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0053
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.9835
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6668
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.2823
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.5687
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0043
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.8662
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3656
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0806
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.5381
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0090
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.9748
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3936
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1563
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6357
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

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 (legacy)
	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
Description	Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to...
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

Outcome Measure Data

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
Arm/Group Description:	Single daily oral dose.	Single daily 50 mg oral dose.	Single daily 100 mg oral dose. Dose...	Single daily 150 mg oral dose. Dose...	Single daily 300 mg oral dose. Dose...	Single daily 450 mg oral dose. Dose...
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)

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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
Description	Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to...
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

Outcome Measure Data

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
Arm/Group Description:	Single daily oral dose.	Single daily 50 mg oral dose.	Single daily 100 mg oral dose. Dose...	Single daily 150 mg oral dose. Dose...	Single daily 300 mg oral dose. Dose...	Single daily 450 mg oral dose. Dose...
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)

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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
Description	Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to...
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

Outcome Measure Data

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
Arm/Group Description:	Single daily oral dose.	Single daily 50 mg oral dose.	Single daily 100 mg oral dose. Dose...	Single daily 150 mg oral dose. Dose...	Single daily 300 mg oral dose. Dose...	Single daily 450 mg oral dose. Dose...
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)

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

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 (legacy)
	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]

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Placebo, Pregabalin 300 mg
	Comments	Week 5: Contrast of treatment vs. placebo. Repeated measures mode