Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy
NCT ID: NCT04857359
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
25 participants
INTERVENTIONAL
2021-08-06
2022-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dipraglurant TID
Dipraglurant
Oral 50mg and 100mg tablet
Placebo TID
Placebo
Oral matching placebo tablet
Interventions
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Dipraglurant
Oral 50mg and 100mg tablet
Placebo
Oral matching placebo tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
30 Years
85 Years
ALL
No
Sponsors
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Addex Pharma S.A.
INDUSTRY
Responsible Party
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Locations
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Xenosciences Inc
Phoenix, Arizona, United States
Neuro-Pain Medical Center
Fresno, California, United States
University of California Irvine Medical Center
Irvine, California, United States
Stanford Neuroscience Health Center
Palo Alto, California, United States
Pacific Neuroscience Institute
Torrance, California, United States
Rocky Mountain Movement Disorders Center
Englewood, Colorado, United States
Chase Family Movement Disorders Center - Vernon
Vernon, Connecticut, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton Inc
Boca Raton, Florida, United States
Renstar Medical Research -21 NE 1st Ave
Ocala, Florida, United States
AES - DRS - Synexus Clinical Research US, Inc. - Orlando
Orlando, Florida, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States
Suncoast Neuroscience Associates Inc
St. Petersburg, Florida, United States
University of South Florida
Tampa, Florida, United States
Geodyssey Research LLC
Vero Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
NeuroStudies.net, LLC - ClinEdge - PPDS
Decatur, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Josephson Wallack Munshower Neurology PC
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Henry Ford Health System
Bingham Farms, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Cooper University Hospital
Camden, New Jersey, United States
Rutgers, the State University of New Jersey
New Brunswick, New Jersey, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
David L Kreitzman MD PC
Commack, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Toledo, Gardner-McMaster Parkinson Center
Toledo, Ohio, United States
Abington Neurologic Associates
Abington, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Avera Medical Group
Sioux Falls, South Dakota, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Health Science Center, San Antonio
San Antonio, Texas, United States
Meridian Clinical Research (Norfolk, Virginia)
Norfolk, Virginia, United States
Sentara Neurology Specialists
Virginia Beach, Virginia, United States
Evergreen Hospital Medical Center
Kirkland, Washington, United States
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, United States
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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ADX48621-301
Identifier Type: -
Identifier Source: org_study_id
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