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Terminated prior to completing enrollment goals due to COVID-related difficulties in recruiting patients
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dipraglurant TID | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dipraglurant | Drug | Oral 50 mg and 100 mg tablet |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augusta University | Augusta | Georgia | 30912 | United States | ||
| University of Kansas Medical Center |
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| Kansas City |
| Kansas |
| 66160 |
| United States |
| Rutgers, the State University of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210-1267 | United States |
| Abington Neurologic Associates | Abington | Pennsylvania | 19001-3816 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D004409 | Dyskinesia, Drug-Induced |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D020258 | Neurotoxicity Syndromes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011041 | Poisoning |
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| ID | Term |
|---|---|
| C000596095 | 6-fluoro-2-(4-(pyridin-2-yl)but-3-yn-1-yl)imidazo(1,2-a)pyridine |
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