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A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00855738
Recruitment Status : Completed
First Posted : March 4, 2009
Results First Posted : July 23, 2010
Last Update Posted : December 10, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Focal Epilepsy
Intervention Drug: Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide
Enrollment 111
Recruitment Details  
Pre-assignment Details Given the observational nature of the study, the selection of treatment and dose of study medication was independent from participation in the study and was determined by daily clinical practice.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Period Title: Overall Study
Started 111
At Least 1 Dose and 1 Endpoint 108 [1]
Completed 106
Not Completed 5
Reason Not Completed
Lost to Follow-up             2
Adverse Event             1
Subject Defaulted             1
Death             1
[1]
Received at least 1 dose of study drug and had data for at least 1 efficacy endpoint.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Baseline Participants 111
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants
45.3  (16.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Female
52
  46.8%
Male
59
  53.2%
1.Primary Outcome
Title Percent of Participants Classified as Responders
Hide Description Responder = decrease in number of seizures by >=50 percent (%) during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the number of seizures that occurred during the 3 months before the baseline visit (baseline).
Time Frame Baseline, Month 3, Month 6 (last 3 months of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): intent-to-treat population = those who took at least 1 dose of study medication and had post-baseline data for at least 1 efficacy endpoint. Last Observation Carried Forward (LOCF) captures last 3 months of treatment for subjects who discontinued between Month 3 and Month 6 only. N=number of subjects with evaluable data.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
Month 3
76.7
(66.6 to 84.9)
Month 6
80.0
(70.2 to 87.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Month 3: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Month 6: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
2.Secondary Outcome
Title Percent of Participants With Reduction in Number of Seizures >=25% and >=75% During the Last 3 Months of Treatment
Hide Description Percent of participants with reduction in number of seizures >=25% and >=75% during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the 3 month period before the baseline visit.
Time Frame Baseline, Month 3, Month 6 (last 3 months of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF. N=number of subjects with evaluable data.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
Month 3: >=25%
86.7
(77.9 to 92.9)
Month 3: >=75%
27.8
(18.8 to 38.2)
Month 6: >= 25%
86.7
(77.9 to 92.9)
Month 6: >=75%
54.4
(43.6 to 65.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Month 3 >=25% reduction: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Month 3 >=75% reduction: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Month 6: >=25% reduction: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Month 6: >=75% reduction: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
3.Secondary Outcome
Title Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation
Hide Description [Not Specified]
Time Frame Baseline, Month 3, Month 6 (last 3 months of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF. N=number of subjects with evaluable data.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
Month 3
10.0
(4.7 to 18.1)
Month 6
20.0
(12.3 to 29.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Month 3: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0039
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Month 6: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline in the Median Number of Seizures During the Last 3 Months of Treatment
Hide Description [Not Specified]
Time Frame Baseline, Month 3, Month 6 (last 3 months of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS LOCF. N=number of subjects with evaluable data.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 90
Median (Inter-Quartile Range)
Unit of Measure: percent change
-75.0
(-88.9 to -50.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
5.Secondary Outcome
Title Percent of Days Without Crisis During the Study
Hide Description Crisis was defined as the total number of seizures during the study, the seizures at month 3 plus the seizures at month 6. The percent of days without crisis is number of days of study (date of last visit minus date of baseline visit) without crisis divided by number of days of study, multiplied by 100.
Time Frame Baseline through Month 6 (or end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The percentage of days without crisis during the study was not evaluable because a diary with the daily number of crises was not collected.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Time to First Seizure
Hide Description Number of days to first seizure after baseline.
Time Frame Baseline to Month 6 (or end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS LOCF. N=number of subjects with evaluable data.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 79
Mean (Standard Deviation)
Unit of Measure: days
35.9  (40.2)
7.Secondary Outcome
Title Percent of Participants Who Continued on Study Medication to Month 6
Hide Description Retention rate: percent of participants who continued on study medication throughout the 6 Month period after inclusion in the study.
Time Frame Baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percent of participants
97.1
8.Secondary Outcome
Title Time to Discontinuation Due to Lack of Efficacy
Hide Description [Not Specified]
Time Frame Baseline, Month 3, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF. As no participants discontinued due to lack of efficacy, the time to exit analysis was not performed.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Time to Discontinuation Due to Safety, Tolerability, or Treatment Compliance
Hide Description [Not Specified]
Time Frame Baseline, Month 3, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF. Due to the low number of participants who discontinued due to safety, tolerability or compliance with treatment, the time to exit analysis was not performed.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Time to Discontinuation Due to Other Reasons
Hide Description [Not Specified]
Time Frame Baseline, Month 3, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF. Due to the low number of participants who discontinued due to other reasons, the time to exit analyses was not performed.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Treatment Satisfaction Evaluated by Patient Global Impression of Change Visual Analog Scale (VAS)
Hide Description Patient Global Impression of Change VAS: subject rated instrument to measure subject's change in overall status; range from 0 (much better) to 10 (much worse).
Time Frame Baseline, Month 3, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF. The scale for this endpoint was not collected and results were not analyzed as planned.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Percent of Participants Reaching Monotherapy
Hide Description Percent of participants who started on more than one treatment (bitherapy) and reached monotherapy by end of study.
Time Frame Baseline through Month 6 (or end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF. N=number of participants who started on bitherapy.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 105
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of partipants
2.9
(0.6 to 8.1)
13.Secondary Outcome
Title Percent of Participants That Reduced, Maintained and Increased Their Doses of New Antiepileptic Drugs (AED)
Hide Description [Not Specified]
Time Frame Baseline to Month 6 (or end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
Reduced
0.9
(0.0 to 5.1)
Maintained
68.5
(58.9 to 77.1)
Increased
30.6
(22.1 to 40.2)
14.Secondary Outcome
Title Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy
Hide Description [Not Specified]
Time Frame Baseline through Month 6 (or end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF. N= number of subjects with initial treatment administered as monotherapy.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: percent of participants
Reduced 0.0
Maintained 100.0
Increased 0.0
15.Secondary Outcome
Title Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS)
Hide Description HADS: subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame Baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF. N=number of subjects with evaluable data.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: scores on scale
Depression -0.5  (3.5)
Anxiety -0.6  (3.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Depression domain: P-value vs baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1797
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Anxiety domain: P-value vs baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0433
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline to Month 6 in Quality of Life 10 Domains (QOLIE-10)
Hide Description QOLIE-10: 10-item questionnaire evaluates health-related quality of life in individuals with epliepsy. Comprised of 7 components: seizure worry, overall quality of life, emotional well-being, energy, cognitive functioning, medication effects (physical and mental effects), and social function (work, driving, social function). Total score rated 0 to 100; higher score = higher quality of life.
Time Frame Baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF. N=number of subjects with evaluable data.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 107
Mean (Standard Deviation)
Unit of Measure: scores on scale
Energy 0.4  (17.8)
Emotions (mood) 0.7  (16.0)
Daily activities 0.6  (12.9)
Mental function 1.2  (20.8)
Medication effects (physical/ mental) -1.1  (14.9)
Worry about seizures (impact of seizures) 9.0  (21.1)
Overall quality of life 3.8  (17.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Energy: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8284
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Emotions (mood): p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6299
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Daily activities: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6162
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Mental function: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5609
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Medication effects (physical/ mental): p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4635
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Worry about seizures (impact of seizures): p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Overall quality of life: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0258
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline to Months 3 and 6 in Health Condition: Euro Quality of Life Scale (EQ-5D) Visual Analog Scale (VAS)
Hide Description Assessment of the health condition of the subjects using the EQ-5D VAS: subject rated questionnaire to assess health-related quality of life in terms of a single index value. Using the VAS subjects rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Time Frame Baseline, Month 3, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS LOCF. N=number of subjects with evaluable data.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: scores on scale
Month 3 -0.4  (16.2)
Month 6 1.2  (15.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Month 3: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7822
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Month 6: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4471
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
18.Secondary Outcome
Title Change in Sleep Disturbances From Baseline to Month 6: Medical Outcomes Study Sleep Scale (MOS-SS)
Hide Description Subject rated instrument to assess key constructs of sleep; assesses sleep quality and quantity. Consists of a 6-item and 9-item overall sleep problems index measuring time to fall asleep and sleep duration in past 4 weeks; 5 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy. Transformed scores range = 0 to 100; higher score indicates greater intensity of attribute. Two additional subscales = sleep quantity (range 0-24 hours) and optimal sleep (number of participants with optimal sleep 7-8 hours per night).
Time Frame Baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS LOCF. Change from baseline in Optimal sleep is not shown as changes from baseline were only evaluated for continuous parameters. N=number of subjects with evaluable data.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 107
Mean (Standard Deviation)
Unit of Measure: scores on scale
Sleep disturbance -1.7  (15.1)
Snoring 0.0  (15.6)
Awake short of breath 1.1  (14.6)
Quantity 0.2  (0.8)
Adequacy 2.8  (15.0)
Somnolence 0.6  (11.0)
Sleep problems (summary 6) -0.9  (11.7)
Sleep problems (summary 9) -0.9  (13.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Sleep disturbance: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2452
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Snoring: p-value verus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Awake short of breath: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4253
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Quantity: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0572
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Adequacy: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0625
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Somnolence: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5540
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Sleep problems (summary 6): p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4204
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Sleep problems (summary 9): p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4869
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
19.Secondary Outcome
Title Percent of Participants Indicating Optimal Sleep on the Optimal Sleep Subscale: Medical Outcomes Study Sleep Scale (MOS-SS)
Hide Description MOS-SS: subject rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Optimal sleep subscale is derived from sleep quantity average hours of sleep over the past 4 weeks; percent of participants with response YES (optimal) if sleep quantilty was 7-8 hours of sleep per night.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percent of participants
Baseline 56.5
Month 6 65.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Month 6: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0863
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline to Month 6 in Visits to a Specialist or the Emergency Room Because of Epilepsy
Hide Description Numerical assessment of change in the number of visits to a specialist or the emergency room because of epilepsy needed during the study.
Time Frame Baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF. Costs involved in health and non-health resources needed during the study were not analyzed as planned with this endpoint. N=number of subjects with visits to a specialist because of epilepsy.
Arm/Group Title All Antiepileptic Drugs
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Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: visits
Number of visits to a specialist (n=94) -0.6  (2.3)
Number of visits to the emergency room (n=79) -0.3  (0.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Number of visits to a specialist because of epilepsy: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0226
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Number of visits to the emergency room because of epilepsy: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline to Month 6 in Total Number of Days Hospitalized Because of Epilepsy
Hide Description Numerical assessment of change in total number of days hospitalized because of epilepsy during the study.
Time Frame Baseline to Month 6
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Hide Analysis Population Description
FAS; LOCF. N=number of subjects with evaluable data.
Arm/Group Title All Antiepileptic Drugs
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Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 76
Mean (Standard Deviation)
Unit of Measure: Days
-8.0  (68.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments P-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3141
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
22.Secondary Outcome
Title Percent of Participants With Cessation of Occupation, Requirement of Caregiver, or Admission to Intensive Care Unit
Hide Description Percent of participants with cessation of usual occupation, requirement of an informal caregiver, and who required admission to the intensive care unit (ICU).
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF.
Arm/Group Title All Antiepileptic Drugs
Hide Arm/Group Description:
Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percent of participants
Stopped Usual Occupation 16.2
Required Informal Caregiver 6.6
Required Admission to ICU 0.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Cessation of usual occupation: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0708
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Requirement of informal caregiver: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Antiepileptic Drugs
Comments Required admission to ICU: p-value versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Includes data from baseline to 7 days after last dose of study drug.
Adverse Event Reporting Description Safety Population: subjects known to have taken at least one dose of study medication.
 
Arm/Group Title All Antiepileptic Drugs (Including Pregabalin) Pregabalin (Pregabalin Only)
Hide Arm/Group Description Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin [Not Specified]
All-Cause Mortality
All Antiepileptic Drugs (Including Pregabalin) Pregabalin (Pregabalin Only)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
All Antiepileptic Drugs (Including Pregabalin) Pregabalin (Pregabalin Only)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/111 (0.00%)   0/40 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Antiepileptic Drugs (Including Pregabalin) Pregabalin (Pregabalin Only)
Affected / at Risk (%) Affected / at Risk (%)
Total   7/111 (6.31%)   5/40 (12.50%) 
General disorders     
Asthenia  1  1/111 (0.90%)  0/40 (0.00%) 
Investigations     
Weight increased  1  2/111 (1.80%)  2/40 (5.00%) 
Nervous system disorders     
Dizziness  1  1/111 (0.90%)  1/40 (2.50%) 
Somnolence  1  4/111 (3.60%)  3/40 (7.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
This study was cancelled with 111 patients enrolled due to lack of recruitment, and inability to analyze the study by treatment groups. Seizures were analyzed by 3 month data instead of 2 month data as originally planned.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00855738    
Other Study ID Numbers: A0081144
LICEO STUDY
First Submitted: March 3, 2009
First Posted: March 4, 2009
Results First Submitted: June 23, 2010
Results First Posted: July 23, 2010
Last Update Posted: December 10, 2010