title: A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  AQW051 did not significantly reduce dyskinesia or parkinsonian severity. © 2016 International Parkinson and Movement Disorder Society.
authors.affiliation: Paracelsus-Elena Hospital, Kassel, Germany.|Department of Neurosurgery, University Medical Center, Goettingen, Germany.|German Parkinson Study Group, Marburg, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: Trenkwalder
authors.affiliation: German Parkinson Study Group, Marburg, Germany.|Department of Neurodegeneration, Hertie-Institute for Clinical Brain Research and German Center for Neurodegenerative Diseases, Tübingen, Germany.
authors.forename: Daniela
authors.initials: D
authors.lastname: Berg
authors.affiliation: Department of Clinical Pharmacology and Neurosciences, NeuroToul Excellence Center for Neurodegenerative Disorders, University UPS of Toulouse III, CIC-9302/INSERM UMR825, Hôpital Purpan - Pavillon Riser, Toulouse, France.|NS PARK/FCRIN Network, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Rascol
authors.affiliation: German Parkinson Study Group, Marburg, Germany.|Department of Neurology, Philipps-University of Marburg, Marburg, Germany.
authors.forename: Karla
authors.initials: K
authors.lastname: Eggert
authors.affiliation: German Parkinson Study Group, Marburg, Germany.|Schön Klinik München-Schwabing, München, Germany.
authors.forename: Andres
authors.initials: A
authors.lastname: Ceballos-Baumann
authors.affiliation: NS PARK/FCRIN Network, France.|Sorbonne Universités, UPMC Univ Paris 06, and INSERM UMRS 1127 /CIC-1422, and CNRS UMR 7225, and AP-HP, and ICM, Hôpital Pitié-Salpêtrière, Département des maladies du système nerveux, Paris, France.
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Corvol
authors.affiliation: German Parkinson Study Group, Marburg, Germany.|Division of Neurodegenerative Diseases, Department of Neurology, Dresden University of Technology, Dresden, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Storch
authors.affiliation: Department of Neurology, UC Davis MIND Institute, Sacramento, California, USA.
authors.forename: Lin
authors.initials: L
authors.lastname: Zhang
authors.affiliation: NS PARK/FCRIN Network, France.|Service de Neurologie et pathologie du Mouvement, Hôpital de la Timone, Marseille Cedex, France.
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Azulay
authors.affiliation: NS PARK/FCRIN Network, France.|Univisité Lyon 1, Hospices Civils de Lyon, Hôpital Neurologique Pierre Wertheimer, Service de Neurologie C, Lyon, France.|CNRS UMR 5229, Centre de Neurosciences Cognitives, Team Basal Ganglia, Bron, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Broussolle
authors.affiliation: NS PARK/FCRIN Network, France.|Service de Neurologie et Pathologie du movement, EA 1046, CHU de Lille, Hôpital Roger Salengro, Lille, France.
authors.forename: Luc
authors.initials: L
authors.lastname: Defebvre
authors.affiliation: NS PARK/FCRIN Network, France.|Movement to Health (M2H) laboratory, Euromov, University Montpellier 1, Hôpital gui de Chauliac, Montpellier, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Geny
authors.affiliation: Center for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio, USA.
authors.forename: Michal
authors.initials: M
authors.lastname: Gostkowski
authors.affiliation: Department of Neurology, Institute for Research and Medical Care, IROCS, Rome, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Stocchi
authors.affiliation: NS PARK/FCRIN Network, France.|Service de Neurologie, Hôpital de Hautepierre, Strasbourg, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Tranchant
authors.affiliation: NS PARK/FCRIN Network, France.|Centre Investigation Clinique Neurologie, CHU Nantes, Hôpital G&R Laennec, Nantes, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Derkinderen
authors.affiliation: NS PARK/FCRIN Network, France.|Service de Neurologie, Hôpital Gabriel Montpied, Clermont-Ferrand, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Durif
authors.affiliation: Department of Neurology, James J. and Joan A. Gardner Family Center for Parkinson's Disease and Movement Disorders, University of Cincinnati Academic Health Center, Cincinnati, Ohio, USA.
authors.forename: Alberto J
authors.initials: AJ
authors.lastname: Espay
authors.affiliation: Feinstein Institute for Medical Research, North Shore - LIJ Health System, Manhasset, New York, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Feigin
authors.affiliation: NS PARK/FCRIN Network, France.|Service de Neurologie, CIC-INSERM 1402, CHU de Poitiers, Université de Poitiers, Poitiers, France.
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Houeto
authors.affiliation: German Parkinson Study Group, Marburg, Germany.|Klinik Haag, Haag, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Schwarz
authors.affiliation: Neuroscience Research Unit, Centre de recherche du CHU de Québec, Québec, Canada.|Faculty of Pharmacy, Laval University, Québec, Canada.
authors.forename: Thérèse
authors.initials: T
authors.lastname: Di Paolo
authors.affiliation: Novartis Institutes for BioMedical Research, Basel, Switzerland.
authors.forename: Dominik
authors.initials: D
authors.lastname: Feuerbach
authors.affiliation: Novartis Institutes for BioMedical Research, Basel, Switzerland.|Biometrics Matters Ltd, Hamilton, New Zealand.
authors.forename: Hans-Ulrich
authors.initials: HU
authors.lastname: Hockey
authors.affiliation: Albert Einstein College of Medicine, New York, NY, USA, and CognitionMetrics, LLC, Wilmington, Delaware, USA.
authors.forename: Judith
authors.initials: J
authors.lastname: Jaeger
authors.affiliation: Novartis Institutes for BioMedical Research, Basel, Switzerland.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Jakab
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors.forename: Donald
authors.initials: D
authors.lastname: Johns
authors.affiliation: Inbiomed, San Sebastian, Spain.
authors.forename: Gurutz
authors.initials: G
authors.lastname: Linazasoro
authors.affiliation: CogState, Inc, New Haven, Connecticut, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Maruff
authors.affiliation: Novartis Institutes for BioMedical Research, Basel, Switzerland.
authors.forename: Izabela
authors.initials: I
authors.lastname: Rozenberg
authors.affiliation: Novartis Institutes for BioMedical Research, Basel, Switzerland.
authors.forename: Judit
authors.initials: J
authors.lastname: Sovago
authors.affiliation: Novartis Institutes for BioMedical Research, Basel, Switzerland.
authors.forename: Markus
authors.initials: M
authors.lastname: Weiss
authors.affiliation: Novartis Institutes for BioMedical Research, Basel, Switzerland.|Department of Neurology and Neurosurgery, McGill University, Montreal, Québec, Canada.
authors.forename: Baltazar
authors.initials: B
authors.lastname: Gomez-Mancilla
mesh_terms: D000368:Aged; D000978:Antiparkinson Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D053961:Azabicyclo Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D015259:Dopamine Agents / Q000009:adverse effects*; D004311:Double-Blind Method; D004409:Dyskinesia, Drug-Induced / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D007980:Levodopa / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010300:Parkinson Disease / Q000188:drug therapy*; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D064569:alpha7 Nicotinic Acetylcholine Receptor / Q000819:agonists*
chemical_list: C000602881:3-(6-p-tolylpyridin-3-yloxy)-1-azabicyclo(2.2.2)octane; D000978:Antiparkinson Agents; D053961:Azabicyclo Compounds; D015259:Dopamine Agents; D011725:Pyridines; D064569:alpha7 Nicotinic Acetylcholine Receptor; D007980:Levodopa
keywords: AQW051; Parkinson's disease; dyskinesias; levodopa (l-dopa); nicotinic acetylcholine receptor agonist (nAChR) α7