ATLANTA, Dec. 3 /PRNewswire/ -- UCB today announced data demonstrating that anti-epileptic drug (AED) brivaracetam, with the proposed trade name Rikelta(TM), administered as an adjunctive treatment in adults with refractory epilepsy with partial onset seizures, significantly reduced seizure frequency and had a side-effect profile comparable to placebo. The results of the two Phase IIb (Abstracts C.04 and 3.218), double-blind, randomized, parallel- group, placebo-controlled dose ranging studies were presented today as an oral platform presentation at the 61st annual meeting of the American Epilepsy Society.
"It is exciting to see the promising results that brivaracetam produced in this highly refractory population of epilepsy patients," said Jacqueline French, MD, lead study author and professor of neurology at New York University. "The development of novel anti-epilepsy drugs is vital to addressing the needs of treatment-resistant epilepsy patients. We look forward to seeing the results of our Phase III clinical research."
The two studies involved 365 patients, ages 16-65, with refractory
partial onset seizures, which were uncontrolled despite treatment with one
to two other AEDs. Patients in the first study (Abstract C.04) were
randomized to receive 5 mg/day, 20 mg/day, 50 mg/day or placebo,
administered twice-daily without titration over the seven week treatment
period. The study found that brivaracetam reduced weekly seizure frequency
over placebo by 9.8%, 14.9%, and 22.1% with doses of 5mg/day, 20 mg/day,
and 50 mg/day, respectively, suggesting a dose response trend with
brivaracetam 5 mg-50 mg/day.
An analysis of the study's secondary endpoints found that brivaracetam:
-- Reduced median seizure frequency from baseline by 29.9%, 42.6% and
53.1% for 5mg/day, 20mg/day and 50mg/day, respectively, compared with
21.7% for placebo.
-- Reduced weekly seizure frequency from baseline in 32.0%, 44.2% and
|SOURCE UCB, Inc.|
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