Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

Study Overview
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Brief Summary
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This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.

Detailed Description
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After review of the interim analysis results, the independent Data Monitoring Committee (DMC) recommended to stop the study based on positive efficacy findings for the primary efficacy endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation and made the decision to stop the study on September 7, 2011.

Official Title
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A Double-Blind, Randomized, Multicenter Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

Conditions
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Epilepsies, Partial

Intervention / Treatment
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* Drug: pregabalin 600 mg/day
* Drug: pregabalin 150 mg/day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of epilepsy with partial seizures. Males or females, age 18 years or older. Documented history of at least 4 partial seizures in the 8 weeks prior to the screening visit. Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the screening visit. Exclusion Criteria: Current diagnosis of febrile seizures or seizures related to an ongoing acute medical event. Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or infectious origin. Primary generalized epilepsy or status epilepticus within the previous year.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: pregabalin 600 mg/day<br>* pregabalin 600 mg/day (300mg BID), duration is 20 weeks.<br>|
| Experimental: 2<br> | Drug: pregabalin 150 mg/day<br>* pregabalin 150 mg/day (75mg BID), duration is 20 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria | Participants who discontinued due to: episode of status epilepticus (SE); secondarily generalized tonic-clonic (SGTC) seizure if none within 2 years of study entry; 28-day study seizure rate during double-blind phase (DBP) greater than (>)2 times maximum (Max) 28-day study seizure rate during baseline phase (BLP); 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate:(1-Kaplan-Meier [KM] product limit estimate for survival function) * 100% | Week 2 up to Week 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria | Participants who discontinued due to: episode of SE; SGTC seizure if none within 2 years of study entry; 28-day study seizure rate during DBP >2 times Max 28-day study seizure rate during BLP; 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate, defined as (1-KM product limit estimate for survival function) * 100% | Week 2 up to Week 18 | 
| Percentage of Participants Completing 20 Weeks of Double-Blind Treatment |  | Randomization up to Week 20 | 
| Percentage of Participants Who Met Protocol-Specified Exit Events | Percentage of participants experiencing any of the following (could have had more than 1): 1) episode of SE; 2) SGTC seizure if none had been experienced within 2 years of study entry; 3) 28-day study seizure rate during DBP >2 times the Max 28-day study seizure rate during BLP; 4) 2-day study seizure rate during the DBP >2 times the Max 2-day study seizure rate during BLP; or 5) unacceptable clinically significant increase in frequency/intensity of seizure activity | Week 2 up to Week 18 | 
| Mean Time on Pregabalin Monotherapy |  | Week 2 to Week 20 | 
| Percentage of Seizure-Free Participants by Study Phase | Percentage of participants who were seizure-free during the last 28 days on double-blind study medication (monotherapy phase, Days 112-140), during the monotherapy portion of the double-blind treatment phase (Days 56-140), and during all of the double-blind treatment phase (Days 1-140) | Day 1 up to Day 140 | 
| Pregabalin Population Pharmacokinetics (PK) | Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules. | Baseline up to 20 weeks | 
| Pregabalin Exposure-Response Analysis | Percentage of participants predicted to exit the study due to any seizure exit criteria at Day 126. The exit rate at Day 126 was predicted using the final model (log normal distribution with respect to treatment group) and the parameter estimates. | Day 126 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, partial seizures, pregabalin monotherapy, double-blind and randomized trial