Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy With or Without Concomitant Dopaminergic Medications

Conditions
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Parkinson Disease, Dyskinesia, Drug-Induced, Dyskinesias

Intervention / Treatment
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* Drug: Dipraglurant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dipraglurant TID<br> | Drug: Dipraglurant<br>* Oral 50 mg and 100 mg tablet<br>* Other names: ADX48621;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety and tolerability of dipraglurant as measured by incidence of adverse events | Testing the safety and tolerability of dipraglurant in patients with Parkinson's Disease Levodopa-induced dyskinesia based on the incidence of adverse events reported by patients and/or as identified by the Investigator based on clinical assessments conducted during the study. | Baseline (Day 1) to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the continued utility of dipraglurant on dyskinesia as assessed by a change-from-baseline score on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). | The MDS-UPDRS is a Parkinson's Disease (PD) rating scale scored from 0-272; it evaluates progression of disease in patients with PD. A higher score indicates more severe PD. | Baseline (Day 1) to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Dyskinesia, Levodopa-induced Dyskinesia