Conditions: Epilepsies, Partial
Keywords: Partial onset epilepsy Partial onset seizures
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 366
Healthy volunteers: no

Brief summary:
Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures

Detailed description:
Multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with refractory partial onset epilepsy.

Arms:
arm 1: Placebo - four identical tablets taken orally once daily arm 2: 2400mg OXC XR taken orally once daily as four identical tablets arm 3: 1200mg OXC XR taken orally once daily as four identical tablets

Interventions: intervention 1: Placebo intervention 2: 2400mg SPN-804 intervention 3: 1200mg SPN-804
Intervention descriptions: intervention 1: Non-active tablet identical to study drug tablets intervention 2: tablets containing 600mg OXC XR, identical to non-active tablets intervention 3: two active tablets and two non-active tablets, all identical

Protocol document: