Conditions: Epilepsies, Partial
Keywords: Epilepsy partial seizures pregabalin monotherapy double-blind and randomized trial
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 161
Healthy volunteers: no

Brief summary:
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:
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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: pregabalin 600 mg/day intervention 2: pregabalin 150 mg/day
Intervention descriptions: intervention 1: pregabalin 600 mg/day (300mg BID), duration is 20 weeks. intervention 2: pregabalin 150 mg/day (75mg BID), duration is 20 weeks.

Protocol document: