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Terminated prior to completing enrollment goals due to COVID-related difficulties in recruiting patients
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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 weeks at 300 mg per day). The primary efficacy assessment will be based on the Unified Dyskinesia Rating Scale (UDysRS). Patients who complete the 12-week blinded treatment period may have the option to roll into an open-label safety extension study for an additional 12-month treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dipraglurant TID | Experimental |
| |
| Placebo TID | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dipraglurant | Drug | Oral 50mg and 100mg tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on the Unified Dyskinesia Rating Scale (UDysRS) total score | 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. | Baseline (Day 1) to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ON time without troublesome dyskinesia based on a standardized PD diary | 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. | Baseline (Day 1) to Week 12 |
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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 |
|---|---|---|---|---|---|---|
| Xenosciences Inc | Phoenix | Arizona | 85004 | United States | ||
| Neuro-Pain Medical Center |
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| Placebo | Drug | Oral matching placebo tablet |
|
| Change from baseline in OFF time based on a standardized PD diary | 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. | Baseline (Day 1) to Week 12 |
| Fresno |
| California |
| 93710 |
| United States |
| University of California Irvine Medical Center | Irvine | California | 92697 | United States |
| Stanford Neuroscience Health Center | Palo Alto | California | 94304 | United States |
| Pacific Neuroscience Institute | Torrance | California | 90503 | United States |
| Rocky Mountain Movement Disorders Center | Englewood | Colorado | 80113 | United States |
| Chase Family Movement Disorders Center - Vernon | Vernon | Connecticut | 06066 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton Inc | Boca Raton | Florida | 33486 | United States |
| Renstar Medical Research -21 NE 1st Ave | Ocala | Florida | 34471 | United States |
| AES - DRS - Synexus Clinical Research US, Inc. - Orlando | Orlando | Florida | 32806 | United States |
| Neurology Associates of Ormond Beach | Ormond Beach | Florida | 32174 | United States |
| Suncoast Neuroscience Associates Inc | St. Petersburg | Florida | 33712 | United States |
| University of South Florida | Tampa | Florida | 33612-4799 | United States |
| Geodyssey Research LLC | Vero Beach | Florida | 32960 | United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| NeuroStudies.net, LLC - ClinEdge - PPDS | Decatur | Georgia | 30033 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Josephson Wallack Munshower Neurology PC | Indianapolis | Indiana | 46256 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Henry Ford Health System | Bingham Farms | Michigan | 48025-4334 | United States |
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Rutgers, the State University of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| University of New Mexico Health Sciences Center | Albuquerque | New Mexico | 87106-2719 | United States |
| David L Kreitzman MD PC | Commack | New York | 11725 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210-1267 | United States |
| University of Toledo, Gardner-McMaster Parkinson Center | Toledo | Ohio | 43614 | United States |
| Abington Neurologic Associates | Abington | Pennsylvania | 19001-3816 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| Avera Medical Group | Sioux Falls | South Dakota | 57105 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| UT Health Science Center, San Antonio | San Antonio | Texas | 78229-3901 | United States |
| Meridian Clinical Research (Norfolk, Virginia) | Norfolk | Virginia | 23502-3932 | United States |
| Sentara Neurology Specialists | Virginia Beach | Virginia | 23456 | United States |
| Evergreen Hospital Medical Center | Kirkland | Washington | 98034 | United States |
| University of Wisconsin Hospitals and Clinics | Madison | Wisconsin | 53705 | United States |
| Froedtert and The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226-0509 | 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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