Date: 2014-07-23
Type of information: Results
phase: 3
Announcement: results
Company: UCB (Belgium)
Product: brivaracetam
Action mechanism:
Disease: epilepsy
Therapeutic area: CNS diseases - Neurological diseases
Country:
Trial
details: This Phase 3 study was a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam (100 and 200 mg/day) compared to placebo, over a 12-week treatment period, in 768 randomized focal epilepsy patients (aged 16 to 80 years) with partial-onset seizures, not fully controlled despite treatment with one or two concomitant AEDs (NCT01261325). The primary endpoint for the European regulatory authorities is the 50% responder rate for partial-onset seizure frequency compared with placebo, over the treatment period standardized to a 28-day duration. The primary endpoint for the FDA is the percent reduction over placebo for partial-onset seizure frequency, over the treatment period standardized to a 28-day duration. The phase 3 clinical development plan for brivaracetam consisted of the following studies: N01252: an evaluation of the efficacy and safety/tolerability of adjunctive brivaracetam 20, 50, and 100 mg/day compared with placebo over 12 weeks, in 399 randomized patients with partial-onset seizures not fully controlled despite treatment with 1-2 concomitant AEDs. N01253: an evaluation of the efficacy and safety/tolerability of adjunctive brivaracetam at doses of 5, 20, and 50 mg/day compared with placebo over 12 weeks, in 400 randomized patients with partial-onset seizures, not fully controlled despite treatment with 1-2 concomitant AEDs. N01254: an evaluation of the safety and tolerability of adjunctive brivaracetam given at individualized tailored doses between 20 and 150 mg/day, compared with placebo over 16 weeks, in 480 randomized patients (≥16 to 70 years) with uncontrolled epilepsy (up to 20% could be patients with generalized epilepsy), not fully controlled despite treatment with 1-3 concomitant AEDs. N01358: an evaluation of the efficacy and safety of adjunctive brivaracetam 100 and 200 mg/day compared with placebo over 12 weeks in 768 randomized patients (≥16 to 80 years) with partial-onset seizures, not fully controlled despite treatment with 1-2 concomitant AEDs.
Latest
news: * On July 23, 2014, UCB announced positive topline results from the latest Phase 3 study with brivaracetam. This study was designed to evaluate the efficacy and safety of brivaracetam (100 and 200 mg/day, without titration) compared to placebo, as adjunctive treatment in adult focal epilepsy patients with partial-onset seizures, not fully controlled despite treatment with one or two concomitant antiepileptic drugs (AEDs). Results showed that brivaracetam reduced partial-onset seizure frequency and improved responder rates, both with statistical significance. The most commonly reported adverse events were somnolence, dizziness, fatigue and headache. Based on the results of the brivaracetam Phase 3 program, UCB plans to submit a New Drug Application to the FDA and a Marketing Authorization Application to the European Medicines Agency (EMA) in early 2015. Detailed data from this study will be submitted for presentation at upcoming epilepsy congresses and for publications in peer-reviewed journals.
