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A Randomized, Double‐Blind , Controlled Phase II Study of Foliglurax in Parkinson's Disease
Author(s) -
Rascol Olivier,
Medori Rossella,
Baayen Corine,
Such Pedro,
Meulien Didier
Publication year - 2022
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.28970
Subject(s) - dyskinesia , levodopa , clinical endpoint , parkinson's disease , placebo , medicine , movement disorders , randomized controlled trial , double blind , clinical trial , adverse effect , psychology , disease , alternative medicine , pathology
Background Agents targeting the metabotropic glutamate receptor 4 have emerged as a potentially attractive new class of drugs for the treatment of Parkinson's disease ( PD) . Objective The objective of this study was to evaluate the efficacy and safety of foliglurax in reducing off time and dyskinesia in patients with PD. Methods This was a 28‐day, multicenter, randomized, placebo‐controlled, double‐blind clinical trial of foliglurax 10 and 30 mg as adjunct to levodopa in 157 randomly assigned patients with PD and motor complications. Results Although dose‐dependent decreases in daily awake off time were apparent following treatment with foliglurax, the change from baseline to day 28 in off time (primary endpoint) and dyskinesia (secondary endpoint) did not improve significantly compared with placebo for either foliglurax dose. Treatment with foliglurax was generally safe, and there were no relevant safety signals. Conclusions There was no evidence in this study that foliglurax has efficacy in improving levodopa‐induced motor complications in PD. © 2022 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society