TY - JOUR
T1 - A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia
AU - Trenkwalder, Claudia
AU - Berg, Daniela
AU - Rascol, Olivier
AU - Eggert, Karla
AU - Ceballos-Baumann, Andres
AU - Corvol, Jean Christophe
AU - Storch, Alexander
AU - Zhang, Lin
AU - Azulay, Jean Philippe
AU - Broussolle, Emmanuel
AU - Defebvre, Luc
AU - Geny, Christian
AU - Gostkowski, Michal
AU - Stocchi, Fabrizio
AU - Tranchant, Christine
AU - Derkinderen, Pascal
AU - Durif, Franck
AU - Espay, Alberto J.
AU - Feigin, Andrew
AU - Houeto, Jean Luc
AU - Schwarz, Johannes
AU - Di Paolo, Thérèse
AU - Feuerbach, Dominik
AU - Hockey, Hans Ulrich
AU - Jaeger, Judith
AU - Jakab, Annamaria
AU - Johns, Donald
AU - Linazasoro, Gurutz
AU - Maruff, Paul
AU - Rozenberg, Izabela
AU - Sovago, Judit
AU - Weiss, Markus
AU - Gomez-Mancilla, Baltazar
PY - 2016/7/1
Y1 - 2016/7/1
N2 - 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.
AB - 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.
KW - AQW051
KW - dyskinesias
KW - levodopa (l-dopa)
KW - nicotinic acetylcholine receptor agonist (nAChR) α7
KW - Parkinson's disease
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U2 - 10.1002/mds.26569
DO - 10.1002/mds.26569
M3 - Article
C2 - 26990766
AN - SCOPUS:84977576674
VL - 31
SP - 1049
EP - 1054
JO - Movement Disorders
JF - Movement Disorders
SN - 0885-3185
IS - 7
ER -