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