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news.UCB has reported that three randomized, double-blind, placebo-controlled Phase III clinical trials of its antiepileptic drug in development, brivaracetam, are underway, as adjunctive therapy in patients with refractory partial-onset epilepsy. Rikelta is the proposed tradename for brivaracetam.
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Nearly 1300 epilepsy patients, aged between 16 and 70 years, will take part in three trials. Two studies are designed to evaluate the efficacy and safety of brivaracetam (5, 20 and 50mg/day or 20, 50 and 100mg/day) over 12 weeks in patients with partial onset epilepsy, not fully controlled despite treatment with one or two other antiepileptic drugs. The third study with flexible dosing is designed to evaluate the safety and tolerability of brivaracetam in patients with uncontrolled partial onset or primary generalised seizures. First results are expected in Q3 2009.
Iris Loew-Friedrich, global head of development, UCB, said: “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. Today up to 30% of patients can be resistant to current antiepileptic medications and UCB’s R&D programmes aim to support this significant unmet medical need.”