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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Parkinson Disease, Dyskinesia, Drug-Induced, Dyskinesias

In brief

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.

Key facts

Study ID

NCT04857359

Run by

Addex Pharma S.A.

People needed

25

Starts

2021-08-06

Expected to finish

2022-08-15

Last updated by the study team

2025-08-06

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Other protocol-defined inclusion and exclusion criteria may apply

Where it is running

• 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
• Neurology Associates of Ormond Beach — Ormond Beach, Florida, United States
• Suncoast Neuroscience Associates Inc — St. Petersburg, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Geodyssey Research LLC — Vero Beach, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• NeuroStudies.net, LLC - ClinEdge - PPDS — Decatur, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Josephson Wallack Munshower Neurology PC — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Henry Ford Health System — Bingham Farms, Michigan, United States
• Michigan State University — East Lansing, Michigan, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Rutgers, the State University of New Jersey — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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