Conditions: Partial Seizures Epilepsies, Partial
Keywords: Partial epilepsy partial seizures epilepsy seizures adjunctive therapy intervention controlled-release placebo-controlled seizure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 325
Healthy volunteers: no

Brief summary:
Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: pregabalin intervention 2: pregabalin intervention 3: pregabalin intervention 4: pregabalin intervention 5: pregabalin intervention 6: pregabalin intervention 7: placebo
Intervention descriptions: intervention 1: Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days intervention 2: Controlled Release Tablets, 165 mg, once per day (QD) for 11 days intervention 3: Controlled Release Tablets, 330 mg, once per day (QD) for the remainder of the double-blind treatment phase (max is 12 weeks) intervention 4: Controlled Release Tablets, 165 mg, once per day (QD) for 7 days intervention 5: Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days intervention 6: Controlled Release Tablets, 165 mg, once per day (QD) for the remainder of the up-titration and double-blind treatment and taper phases (max 14.5 weeks) intervention 7: matched to the active drug

Protocol document: