Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy
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|ClinicalTrials.gov Identifier: NCT04857359|
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : May 20, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Dyskinesia, Drug-Induced Dyskinesias||Drug: Dipraglurant Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||August 6, 2021|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||August 2023|
|Experimental: Dipraglurant TID||
Oral 50mg and 100mg tablet
Other Name: ADX48621
|Placebo Comparator: Placebo TID||
Oral matching placebo tablet
- Change from baseline on the Unified Dyskinesia Rating Scale (UDysRS) total score [ Time Frame: Baseline (Day 1) to Week 12 ]The UDysRS is a dyskinesia rating scale scored from 0-104 that evaluates involuntary movements associated with PD. A higher score indicates more severe dyskinesia.
- Change from baseline in ON time without troublesome dyskinesia based on a standardized PD diary [ Time Frame: Baseline (Day 1) to Week 12 ]A PD home diary is used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia.
- Change from baseline in OFF time based on a standardized PD diary [ Time Frame: Baseline (Day 1) to Week 12 ]A PD home diary is used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia.
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|Ages Eligible for Study:||30 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857359
|Contact: Study Directoremail@example.com|
|Responsible Party:||Addex Pharma S.A.|
|Other Study ID Numbers:||
|First Posted:||April 23, 2021 Key Record Dates|
|Last Update Posted:||May 20, 2022|
|Last Verified:||May 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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