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

June 1, 2022

Authors: Claudia Trenkwalder, Daniela Berg, Olivier Rascol, Karla Eggert, Andres Ceballos-Baumann, Jean-Christophe Corvol, Alexander Storch, Lin Zhang, Jean-Philippe Azulay, Emmanuel Broussolle, Luc Defebvre, Christian Geny, Michal Gostkowski, Fabrizio Stocchi, Christine Tranchant, Pascal Derkinderen, Franck Durif, Alberto J Espay, Andrew Feigin, Jean-Luc Houeto, Johannes Schwarz, Thérèse Di Paolo, Dominik Feuerbach, Hans-Ulrich Hockey, Judith Jaeger, Annamaria Jakab, Donald Johns, Gurutz Linazasoro, Paul Maruff, Izabela Rozenberg, Judit Sovago, Markus Weiss, Baltazar Gomez-Mancilla

Journal: Movement Disorders

DOI: 10.1002/mds.26569

Year Published: 2016

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.

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