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Mavoglurant in Parkinson's patients with l ‐Dopa‐induced dyskinesias: Two randomized phase 2 studies
Author(s) -
Trenkwalder Claudia,
Stocchi Fabrizio,
Poewe Werner,
Dronamraju Nalina,
Kenney Chris,
Shah Amy,
von Raison Florian,
Graf Ana
Publication year - 2016
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.26585
Subject(s) - placebo , dyskinesia , medicine , randomized controlled trial , adverse effect , statistical significance , movement disorders , parkinson's disease , anesthesia , psychology , alternative medicine , disease , pathology
Background 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. Methods 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. Results 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. Conclusions Both studies failed to meet the primary objective of demonstrating improvement of dyskinesia with mavoglurant treatment. © 2016 International Parkinson and Movement Disorder Society