A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia.

TitleA Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia.
Publication TypeJournal Article
Year of Publication2016
AuteursTrenkwalder, C, Berg, D, Rascol, O, Eggert, K, Ceballos-Baumann, A, Corvol, J-C, Storch, A, Zhang, L, Azulay, J-P, Broussolle, E, Defebvre, L, Geny, C, Gostkowski, M, Stocchi, F, Tranchant, C, Derkinderen, P, Durif, F, Espay, AJ, Feigin, A, Houeto, J-L, Schwarz, J, Di Paolo, T, Feuerbach, D, Hockey, H-U, Jaeger, J, Jakab, A, Johns, D, Linazasoro, G, Maruff, P, Rozenberg, I, Sovago, J, Weiss, M, Gomez-Mancilla, B
JournalMov Disord
Volume31
Issue7
Pagination1049-54
Date Published2016 Jul
ISSN1531-8257
Abstract

BACKGROUND: This phase 2 randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of the nicotinic acetylcholine receptor α7 agonist AQW051 in patients with Parkinson's disease and levodopa-induced dyskinesia.METHODS: Patients with idiopathic Parkinson's disease and moderate to severe levodopa-induced dyskinesia were randomized to AQW051 10 mg (n = 24), AQW051 50 mg (n = 24), or placebo (n = 23) once daily for 28 days. Coprimary end points were change in Modified Abnormal Involuntary Movement Scale and Unified Parkinson's Disease Rating Scale part III scores. Secondary outcomes included pharmacokinetics.RESULTS: In total, 67 patients completed the study. AQW051-treated patients experienced no significant improvements in Modified Abnormal Involuntary Movement Scale or Unified Parkinson's Disease Rating Scale part III scores by day 28. AQW051 was well tolerated; the most common adverse events were dyskinesia, fatigue, nausea, and falls.CONCLUSIONS: AQW051 did not significantly reduce dyskinesia or parkinsonian severity. © 2016 International Parkinson and Movement Disorder Society.

DOI10.1002/mds.26569
Alternate JournalMov. Disord.
PubMed ID26990766