Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy
Stopped early · Phase 2/Phase 3
Conditions studied: Parkinson Disease, Dyskinesia, Drug-Induced, Dyskinesias
In brief
This open-label study is designed to assess the long-term safety and tolerability of dipraglurant in PD patients for up to 52 weeks (at doses of 150-300 mg per day) for patients that have completed an Addex sponsored double-blind clinical trial of dipraglurant.
Key facts
- Study ID
- NCT05116813
- Run by
- Addex Pharma S.A.
- People needed
- 17
- Starts
- 2021-10-25
- 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…
- Completed an Addex randomized controlled study of dipraglurant and, in the judgement of the Investigator, may benefit from open-label treatment
- Able to take study drug 3 times daily and no less than 3 hours apart
- Must be taking levodopa not less than 3 times daily throughout the study
- Must maintain stable regimen of antiparkinson's medications (including levodopa) and be willing to continue the same doses and regimens for the first 4 weeks of the study
You may not qualify if…
- Patient is judged by the Investigator to be inappropriate for the study (for reasons such as, but not limited to, significant noncompliance in the Addex randomized controlled study of dipraglurant)
- Use of amantadine or amantadine ER throughout the study
- Use of memantine throughout the study
- Any use of marijuana or other cannabis/cannabinoid products for the first 4 weeks of study participation
- Other protocol-defined inclusion and exclusion criteria may apply
Where it is running
- Augusta University — Augusta, Georgia, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Rutgers, the State University of New Jersey — New Brunswick, New Jersey, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
- Abington Neurologic Associates — Abington, Pennsylvania, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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