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A Placebo‐Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa‐Induced Dyskinesia
Author(s) -
Trenkwalder Claudia,
Berg Daniela,
Rascol Olivier,
Eggert Karla,
CeballosBaumann Andres,
Corvol JeanChristophe,
Storch Alexander,
Zhang Lin,
Azulay JeanPhilippe,
Broussolle Emmanuel,
Defebvre Luc,
Geny Christian,
Gostkowski Michal,
Stocchi Fabrizio,
Tranchant Christine,
Derkinderen Pascal,
Durif Franck,
Espay Alberto J.,
Feigin Andrew,
Houeto JeanLuc,
Schwarz Johannes,
Di Paolo Thérèse,
Feuerbach Dominik,
Hockey HansUlrich,
Jaeger Judith,
Jakab Annamaria,
Johns Donald,
Linazasoro Gurutz,
Maruff Paul,
Rozenberg Izabela,
Sovago Judit,
Weiss Markus,
GomezMancilla Baltazar
Publication year - 2016
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.26569
Subject(s) - dyskinesia , levodopa , placebo , medicine , nausea , movement disorders , parkinson's disease , rating scale , psychology , anesthesia , adverse effect , physical therapy , disease , pathology , developmental psychology , alternative medicine
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