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TERMINATEDPHASE2/PHASE3

Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy

Phase 2b/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Dipraglurant (ADX48621) for the Treatment of Dyskinesia in Patients With Parkinson's Disease Receiving Levodopa-based Therapy

NCT04857359•Addex Pharma S.A.

View on ClinicalTrials.gov

Summary

This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day). The primary efficacy assessment will be based on the Unified Dyskinesia Rating Scale (UDysRS). Patients who complete the 12-week blinded treatment period may have the option to roll into an open-label safety extension study for an additional 12-month treatment period.

Eligibility

Age

30 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with Parkinson's Disease on a stable regimen of antiparkinson's medications, including a levodopa preparation administered not less than 3 times daily.
•Meet protocol-specified criteria for moderate to severe dyskinesia symptoms based on UDysRS and Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assessments.
•Meet protocol specified criteria for ON time with troublesome dyskinesia based on a standard PD home diary.

Exclusion Criteria

•Prior surgical treatment for Parkinson's Disease (e.g., deep brain stimulation).
•Other neurological disease (including psychiatric disease and/or cognitive impairment) that, in the opinion of the investigator, would affect the patient's ability to complete study assessments.
•Other significant medical condition that may affect the safety of the patient or preclude adequate participation in the study.
•Pregnant or breast-feeding. Female patients who are of child-bearing potential must be using adequate contraceptive methods (e.g. oral contraceptive, double-barrier method, intra-uterine device, intra-muscular hormonal contraceptive), and have a negative pregnancy test at Screening.

Locations (41)

Xenosciences Inc

Phoenix, Arizona, United States

Neuro-Pain Medical Center

Fresno, California, United States

University of California Irvine Medical Center

Irvine, California, United States

Stanford Neuroscience Health Center

Palo Alto, California, United States

Pacific Neuroscience Institute

Torrance, California, United States

Rocky Mountain Movement Disorders Center

Englewood, Colorado, United States

Chase Family Movement Disorders Center - Vernon

Vernon, Connecticut, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton Inc

Boca Raton, Florida, United States

Renstar Medical Research -21 NE 1st Ave

Ocala, Florida, United States

AES - DRS - Synexus Clinical Research US, Inc. - Orlando

Orlando, Florida, United States

Key Dates

Start Date

August 6, 2021

Primary Completion Date

June 17, 2022

Completion Date

August 15, 2022

Last Updated

August 6, 2025

Enrollment

ACTUAL participants

Conditions

Parkinson DiseaseDyskinesia, Drug-InducedDyskinesias

Interventions

Dipraglurant

DRUG

Placebo

DRUG

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations