UCB initiates Ph III trials of brivaracetam

Phase III clinical trials of Belgian drugmaker UCB's antiepileptic, brivaracetam, are underway, as adjunctive therapy in patients with refractory partial-onset epilepsy. Rikelta is the proposed trade name for the agent. "The start of the Phase III program for brivaracetam is a key milestone in the advancement of UCB's epilepsy franchise and re-enforces our commitment to the development of new treatment options for people with epilepsy," said Iris Loew-Friedrich, UCB's global head of development. "Today, up to 30% of patients can be resistant to current antiepileptic medications and UCB's R&D programs aim to support this significant unmet medical need," she added.

Nearly 1,300 epilepsy patients, aged between 16 and 70 years, will take part in three multicenter, multinational Phase III trials. Two randomized, double-blind, placebo-controlled studies are designed to evaluate the efficacy and safety of brivaracetam (5mg/day, 20mg/day and 50mg/day or 20mg/day, 50mg/day and 100mg/day) over 12 weeks in patients with partial onset epilepsy, not fully-controlled despite treatment with one or two other antiepileptics. The third study aims to assess the drug's safety and tolerability in uncontrolled partial onset or primary generalized seizures. First results are expected in third-quarter 2009.