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A Randomized, Double‐Blind, Controlled Phase II Study of Foliglurax in Parkinson's Disease

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 dys...

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Autores principales: Rascol, Olivier, Medori, Rossella, Baayen, Corine, Such, Pedro, Meulien, Didier
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9303267/
https://www.ncbi.nlm.nih.gov/pubmed/35218231
http://dx.doi.org/10.1002/mds.28970
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author Rascol, Olivier
Medori, Rossella
Baayen, Corine
Such, Pedro
Meulien, Didier
author_facet Rascol, Olivier
Medori, Rossella
Baayen, Corine
Such, Pedro
Meulien, Didier
author_sort Rascol, Olivier
collection PubMed
description 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
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spelling pubmed-93032672022-07-22 A Randomized, Double‐Blind, Controlled Phase II Study of Foliglurax in Parkinson's Disease Rascol, Olivier Medori, Rossella Baayen, Corine Such, Pedro Meulien, Didier Mov Disord Regular Issue Articles 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 John Wiley & Sons, Inc. 2022-02-26 2022-05 /pmc/articles/PMC9303267/ /pubmed/35218231 http://dx.doi.org/10.1002/mds.28970 Text en © 2022 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Regular Issue Articles
Rascol, Olivier
Medori, Rossella
Baayen, Corine
Such, Pedro
Meulien, Didier
A Randomized, Double‐Blind, Controlled Phase II Study of Foliglurax in Parkinson's Disease
title A Randomized, Double‐Blind, Controlled Phase II Study of Foliglurax in Parkinson's Disease
title_full A Randomized, Double‐Blind, Controlled Phase II Study of Foliglurax in Parkinson's Disease
title_fullStr A Randomized, Double‐Blind, Controlled Phase II Study of Foliglurax in Parkinson's Disease
title_full_unstemmed A Randomized, Double‐Blind, Controlled Phase II Study of Foliglurax in Parkinson's Disease
title_short A Randomized, Double‐Blind, Controlled Phase II Study of Foliglurax in Parkinson's Disease
title_sort randomized, double‐blind, controlled phase ii study of foliglurax in parkinson's disease
topic Regular Issue Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9303267/
https://www.ncbi.nlm.nih.gov/pubmed/35218231
http://dx.doi.org/10.1002/mds.28970
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