Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy
- Conditions
- DyskinesiasDyskinesia, Drug-InducedParkinson Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT04857359
- Lead Sponsor
- Addex Pharma S.A.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 140
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo TID Placebo - Dipraglurant TID Dipraglurant -
- Primary Outcome Measures
Name Time Method Change from baseline on the Unified Dyskinesia Rating Scale (UDysRS) total score 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.
- Secondary Outcome Measures
Name Time Method Change from baseline in ON time without troublesome dyskinesia based on a standardized PD diary 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 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.
Trial Locations
- Locations (41)
Neurology Associates of Ormond Beach
🇺🇸Ormond Beach, Florida, United States
Suncoast Neuroscience Associates Inc
🇺🇸Saint Petersburg, Florida, United States
Geodyssey Research LLC
🇺🇸Vero Beach, Florida, United States
Augusta University
🇺🇸Augusta, Georgia, 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
Avera Medical Group
🇺🇸Sioux Falls, South Dakota, United States
Renstar Medical Research -21 NE 1st Ave
🇺🇸Ocala, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton Inc
🇺🇸Boca Raton, Florida, United States
Henry Ford Health System
🇺🇸Bingham Farms, Michigan, United States
Meridian Clinical Research (Norfolk, Virginia)
🇺🇸Norfolk, Virginia, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
University of California Irvine Medical Center
🇺🇸Irvine, California, United States
Sentara Neurology Specialists
🇺🇸Virginia Beach, Virginia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Josephson Wallack Munshower Neurology PC
🇺🇸Indianapolis, Indiana, United States
Chase Family Movement Disorders Center - Vernon
🇺🇸Vernon, Connecticut, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of New Mexico Health Sciences Center
🇺🇸Albuquerque, New Mexico, United States
David L Kreitzman MD PC
🇺🇸Commack, New York, United States
University of Toledo, Gardner-McMaster Parkinson Center
🇺🇸Toledo, Ohio, United States
Abington Neurologic Associates
🇺🇸Abington, Pennsylvania, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Wisconsin Hospitals and Clinics
🇺🇸Madison, Wisconsin, United States
Rocky Mountain Movement Disorders Center
🇺🇸Englewood, Colorado, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Xenosciences Inc
🇺🇸Phoenix, Arizona, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
UT Health Science Center, San Antonio
🇺🇸San Antonio, Texas, United States
Froedtert and The Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Pacific Neuroscience Institute
🇺🇸Torrance, California, United States
Stanford Neuroscience Health Center
🇺🇸Palo Alto, California, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
NeuroStudies.net, LLC - ClinEdge - PPDS
🇺🇸Decatur, Georgia, United States
Evergreen Hospital Medical Center
🇺🇸Kirkland, Washington, United States
AES - DRS - Synexus Clinical Research US, Inc. - Orlando
🇺🇸Orlando, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States