Journal
MOVEMENT DISORDERS
Volume 25, Issue 7, Pages 896-905Publisher
WILEY
DOI: 10.1002/mds.22974
Keywords
Parkinson's disease; motor fluctuations; dyskinesia; perampanel; AMPA receptor antagonist
Categories
Funding
- German Ministry of Education and Health
- Pitzer Foundation
- Rhon Foundation
- Eisai Co., Ltd.
- Boehringer Ingelheim
- Novartis
- Schwarz Pharma/UCB
- Merck Serono
- Solvay
- Lundbeck
- MJ Fox Foundation for Parkinson's Research
- Rentschler
- ZLB Behring
- University of Marburg
- PSP Association and Weston Trust-The Reta Lila Howard Foundation
- GlaxoSmithKline
- Schering
- Teva Neuroscience
- UCB
- Eisai
- Teva
- Boehringer-Ingelheim
- Orion Pharma
- Schering Plough
- Springer-Verlag, Italy
- Valeant
- Libra (Merck)
- Czech Ministry of Health
- Czech Ministry of Education
- Czech Republic
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Perampanel, a novel, noncompetitive, selective AMPA-receptor antagonist demonstrated evidence of efficacy in reducing motor symptoms in animal models of Parkinson's disease (PD). We assessed the safety and efficacy of perampanel for treatment of wearing off motor fluctuations in patients with PD. Patients (N = 263) were randomly assigned to once-daily add-on 0.5, 1, or 2 mg of perampanel or placebo. The primary objective was to determine whether there was a dose-response relationship for efficacy among the 3 perampanel doses and placebo. The primary efficacy endpoint for each treatment was measured as the least-squares (LS) mean change from baseline to week 12 in percent off' time reduction during the waking day, as recorded by patient diaries. The primary efficacy analysis was a I-sided Williams test for dose-response trend at the 0.025 level of significance. At week 12, dose-response trends, as determined by the Wilhams test, were not statistically significant for LS mean reduction in percent off time during the waking day (P 0.061, with significance defined as P <= 0.025). The 2 higher perampanel doses (ITT population; n = 258) produced nonsignificant reductions from baseline to week 12 in percent off time during the waking day versus placebo (7.59%, P = 0.421 [1 mg], 8.60%, P = 0.257 [2 mg] versus 5.05% [placebo]; significance for pairwise comparisons defined as P <= 0.05). There were no significant changes in dyskinesia or cognitive function in any perampanel group versus placebo. Adverse events were similar across treatment groups. Perampanel treatment was well tolerated and safe, but failed to achieve statistical significance in primary and secondary endpoints. (C) 2010 Movement Disorder Society
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