Status:
TERMINATED
Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy
Lead Sponsor:
Addex Pharma S.A.
Conditions:
Parkinson Disease
Dyskinesia, Drug-Induced
Eligibility:
All Genders
30-85 years
Phase:
PHASE2
PHASE3
Brief 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 we...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04857359
Start Date
August 6 2021
End Date
August 15 2022
Last Update
August 6 2025
Active Locations (41)
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1
Xenosciences Inc
Phoenix, Arizona, United States, 85004
2
Neuro-Pain Medical Center
Fresno, California, United States, 93710
3
University of California Irvine Medical Center
Irvine, California, United States, 92697
4
Stanford Neuroscience Health Center
Palo Alto, California, United States, 94304