A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia
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...
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| Published in | Movement disorders Vol. 31; no. 7; pp. 1049 - 1054 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Blackwell Publishing Ltd
01.07.2016
Wiley Subscription Services, Inc |
| Subjects | |
| Online Access | Get full text |
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| Summary: | 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 |
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| Bibliography: | ark:/67375/WNG-V1N3XH1R-3 ArticleID:MDS26569 istex:3AE462BE0F6441D2C99C4A1022FFC7C0EB724899 Relevant conflicts of interest/financial disclosures Funding agencies Claudia Trenkwalder, Daniela Berg, Olivier Rascol, Karla Eggert, Alexander Storch, and Emmanuel Broussolle have served on advisory boards for Novartis. Claudia Trenkwalder has served on advisory boards and has received honoraria from Britannia, Mundipharma, UCB, and Desitin; has received honoraria from UCB, Desitin Arzneimittel GmbH, and Vifor; and has received grants from Teva, Mundipharma, Michael J. Fox Foundation, BmBF, and EU Horizon 2020. Olivier Rascol has served on advisory boards for AbbVie, Addex, Britannia, Lundbeck, Merck, Sanofi‐Aventis, Servier, Teva, UCB, XenoPort, and Zambon; received honoraria from AbbVie, Britannia, Lilly France, Lundbeck, Merck, MDS, NeuroDerm, Osmotica, Servier, Teva, UCB, and Zambon; and received grants from Agence Nationale de la Recherche (ANR), CHU de Toulouse, France‐Parkinson, INSERM‐DHOS Recherche Clinique Translationnelle, Michael J. Fox Foundation, Programme Hospitalier de Recherche Clinique, Boehringer Ingelheim, Lundbeck, Teva, and UCB. Andres Ceballos‐Baumann, Jean‐Christophe Corvol, Luc Defebvre, and Christian Geny have received honoraria from Novartis. Johannes Schwarz and Gurutz Linazasoro have served as consultants for Novartis and have received honoraria from Novartis; Gurutz Linazasoro has also served on advisory boards for Novartis. Fabrizio Stocchi has served on advisory boards and received honoraria from Novartis. Franck Durif has served on advisory boards for Novartis. Thérèse Di Paolo has a collaborative research contract with Novartis Pharma AG for investigating new compounds in vivo and is also a coauthor on patents with Novartis Pharma AG. Hans‐Ulrich Hockey is an employee of Biometrics Matters Ltd (BML) and served as a contracted statistical consultant to Novartis Pharma AG when working on this article. Paul Maruff is a full‐time employee of CogState Ltd, and Judith Jaeger was a full‐time employee of CogState Ltd at the time of the study. Annamaria Jakab and Judit Sovago are employees of Novartis Pharma AG. Baltazar Gomez‐Mancilla, Dominik Feuerbach, Izabela Rozenberg, and Markus Weiss are employees of, and hold shares in, Novartis Pharma AG; Markus Weiss is also a Novartis patent holder. Donald Johns was a full‐time employee of Novartis at the time of the study. Alberto Espay, Lin Zhang, Jean‐Philippe Azulay, Michal Gostkowski, Christine Tranchant, Pascal Derkinderen, Andrew Feigin, and Jean‐Luc Houeto have declared no financial conflicts of interest related to research covered in this article. This research is sponsored by Novartis Pharmaceuticals, Basel, Switzerland, and also in part by the French “Investissement d'Avenir” program (ANR‐10‐IAIHU‐06). Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals, Basel, Switzerland. ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 ObjectType-News-3 content type line 23 ObjectType-Article-1 ObjectType-Feature-2 |
| ISSN: | 0885-3185 1531-8257 |
| DOI: | 10.1002/mds.26569 |