title: Mavoglurant in Parkinson's patients with l-Dopa-induced dyskinesias: Two randomized phase 2 studies.
abstract: Two phase 2 randomized, double-blind studies were designed to evaluate efficacy and safety of immediate-release (study 1) and modified-release (study 2) mavoglurant formulations in PD l-dopa-induced dyskinesia.
  
  
  
  Patients were randomized to mavoglurant 100-mg or placebo (4:3) groups (study 1) and mavoglurant 200-mg, mavoglurant 150-mg, or placebo (2:1:1) groups (study 2). Primary outcome was antidyskinetic efficacy, as measured by change from baseline to week 12 in modified Abnormal Involuntary Movement Scale total score.
  
  
  
  Differences in least-squares mean (standard error) change in modified Abnormal Involuntary Movement Scale total score in week 12 did not reach statistical significance in either study (study 1: mavoglurant 100 mg twice a day versus placebo, 1.7 [1.31]; study 2: mavoglurant 150 mg twice a day (-1.3 [1.16]) and 200 mg twice a day (-0.2 [1.03]) versus placebo). Adverse events incidence was higher with mavoglurant than with placebo.
  
  
  
  Both studies failed to meet the primary objective of demonstrating improvement of dyskinesia with mavoglurant treatment. © 2016 International Parkinson and Movement Disorder Society.
authors.affiliation: Paracelsus-Elena Klinik, Kassel 34128, Germany; Department of Neurosurgery, University Medical Center, Goettingen, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: Trenkwalder
authors.affiliation: IRCCS San Raffaele Pisana, Rome, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Stocchi
authors.affiliation: Department of Neurology, Medical University, Innsbruck, Austria.
authors.forename: Werner
authors.initials: W
authors.lastname: Poewe
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors.forename: Nalina
authors.initials: N
authors.lastname: Dronamraju
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors.forename: Chris
authors.initials: C
authors.lastname: Kenney
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Shah
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Florian
authors.initials: F
authors.lastname: von Raison
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Ana
authors.initials: A
authors.lastname: Graf
mesh_terms: D000368:Aged; D000978:Antiparkinson Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D015259:Dopamine Agents / Q000009:adverse effects*; D004311:Double-Blind Method; D004409:Dyskinesia, Drug-Induced; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D007980:Levodopa / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010300:Parkinson Disease / Q000188:drug therapy*
chemical_list: D000978:Antiparkinson Agents; D015259:Dopamine Agents; D007211:Indoles; D007980:Levodopa; C581397:mavoglurant
keywords: Parkinson's disease; amantadine; levodopa-induced dyskinesia; mGluR5 antagonist; mavoglurant