Abstract | BACKGROUND:
Perampanel is a selective, noncompetitive α-amino-3-hydroxy-5-methyl-4-isoxazole-propionic acid receptor antagonist. Two multicenter randomized, double-blind, placebo-controlled, parallel-group phase III studies assessed the efficacy and safety of adjunctive perampanel in patients with Parkinson's disease and motor fluctuations. METHODS: In both phase III studies (301 and 302), levodopa-treated patients were randomized and treated with once-daily oral placebo (n = 504), perampanel 2 mg (n = 509), or perampanel 4 mg (n = 501). The primary end point was change in daily "off" time from baseline. The treatment period was 30 weeks in study 301 and 20 weeks in study 302. RESULTS: For any efficacy end point, perampanel 2 or 4 mg was not superior to placebo. Perampanel was well tolerated up to 4 mg/day. CONCLUSIONS:
Perampanel failed to significantly improve motor symptoms versus placebo. There was also no effect on the duration or disability of levodopa-induced dyskinesia.
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Authors | Andrew Lees, Stanley Fahn, Karla M Eggert, Joseph Jankovic, Anthony Lang, Federico Micheli, M Maral Mouradian, Wolfgang H Oertel, C Warren Olanow, Werner Poewe, Olivier Rascol, Eduardo Tolosa, David Squillacote, Dinesh Kumar |
Journal | Movement disorders : official journal of the Movement Disorder Society
(Mov Disord)
Vol. 27
Issue 2
Pg. 284-8
(Feb 2012)
ISSN: 1531-8257 [Electronic] United States |
PMID | 22161845
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2011 Movement Disorder Society. |
Chemical References |
- Excitatory Amino Acid Antagonists
- Nitriles
- Pyridones
- perampanel
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Topics |
- Aged
- Dose-Response Relationship, Drug
- Double-Blind Method
- Excitatory Amino Acid Antagonists
(therapeutic use)
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Nitriles
- Parkinson Disease
(drug therapy)
- Pyridones
(therapeutic use)
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