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UCB announced today top-line results from two phase III clinical studies to assess the efficacy and safety of brivaracetam as adjunctive treatment of partial-onset seizures in adults with epilepsy. Results were also announced for a third well-controlled safety and tolerability study.
Study N01253 achieved statistical significance in its primary efficacy endpoint, showing that adjunctive treatment with brivaracetam was associated with significant reductions in seizure frequency versus placebo.
Study N01252 did not achieve statistical significance on the primary efficacy endpoint. Data from all three studies (N01252/1253/1254) confirmed that brivaracetam was generally well tolerated, with the majority of adverse events reported being mild to moderate in nature.
“Further analysis of both the primary and secondary endpoints of these Phase three studies is needed to better understand the potential of the drug,” said Prof Dr Iris Löw-Friedrich, Chief Medical Officer of UCB.
“Upon first analysis of the phase three studies, the efficacy observed appears to differ between different patient subpopulations. We need to complete our review of all relevant data and will decide our next steps to bring brivaracetam to patients, after consulting with regulatory authorities.”
Nearly 1,300 epilepsy patients, aged between 16 and 70 years, took part in the three multicentre, multinational phase III studies. The studies were undertaken following promising efficacy and tolerability data for brivaracetam in the phase IIb program.
Two randomised, double-blind, placebo-controlled studies were designed to evaluate the efficacy and safety of adjunctive brivaracetam (5, 20 and 50 mg/day or 20, 50 and 100 mg/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 was a randomized, double-blind, placebo-controlled trial with flexible dosing designed to evaluate the safety and tolerability of brivaracetam over 16 weeks in patients with uncontrolled partial onset or primary generalised seizures, not fully controlled despite treatment with one to three other antiepileptic drugs. All ongoing clinical trials with brivaracetam are continuing.