Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy

NCT04857359 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: ADX48621-301
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 41

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.

Conditions

Parkinson Disease; Dyskinesia, Drug-Induced; Dyskinesias

Keywords

Parkinson's disease; Dyskinesia; Levodopa-induced Dyskinesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change from baseline in ON time without troublesome dyskinesia based on a standardized PD diary

  Baseline (Day 1) to Week 12

• Change from baseline in OFF time based on a standardized PD diary

  Baseline (Day 1) to Week 12

Study Arms (2)

Dipraglurant TID

EXPERIMENTAL

Drug: Dipraglurant

Placebo TID

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dipraglurant DRUG

Oral 50mg and 100mg tablet

Also known as: ADX48621

Dipraglurant TID

Placebo DRUG

Oral matching placebo tablet

Placebo TID

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Addex Pharma S.A.: lead

Study Sites (41)

Xenosciences Inc

Phoenix, Arizona, 85004, United States

Location

Neuro-Pain Medical Center

Fresno, California, 93710, United States

Location

University of California Irvine Medical Center

Irvine, California, 92697, United States

Location

Stanford Neuroscience Health Center

Palo Alto, California, 94304, United States

Location

Pacific Neuroscience Institute

Torrance, California, 90503, United States

Location

Rocky Mountain Movement Disorders Center

Englewood, Colorado, 80113, United States

Location

Chase Family Movement Disorders Center - Vernon

Vernon, Connecticut, 06066, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton Inc

Boca Raton, Florida, 33486, United States

Location

Renstar Medical Research -21 NE 1st Ave

Ocala, Florida, 34471, United States

Location

AES - DRS - Synexus Clinical Research US, Inc. - Orlando

Orlando, Florida, 32806, United States

Location

Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

Suncoast Neuroscience Associates Inc

St. Petersburg, Florida, 33712, United States

Location

University of South Florida

Tampa, Florida, 33612-4799, United States

Location

Geodyssey Research LLC

Vero Beach, Florida, 32960, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

NeuroStudies.net, LLC - ClinEdge - PPDS

Decatur, Georgia, 30033, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Josephson Wallack Munshower Neurology PC

Indianapolis, Indiana, 46256, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Henry Ford Health System

Bingham Farms, Michigan, 48025-4334, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Rutgers, the State University of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87106-2719, United States

Location

David L Kreitzman MD PC

Commack, New York, 11725, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210-1267, United States

Location

University of Toledo, Gardner-McMaster Parkinson Center

Toledo, Ohio, 43614, United States

Location

Abington Neurologic Associates

Abington, Pennsylvania, 19001-3816, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Avera Medical Group

Sioux Falls, South Dakota, 57105, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

UT Health Science Center, San Antonio

San Antonio, Texas, 78229-3901, United States

Location

Meridian Clinical Research (Norfolk, Virginia)

Norfolk, Virginia, 23502-3932, United States

Location

Sentara Neurology Specialists

Virginia Beach, Virginia, 23456, United States

Location

Evergreen Hospital Medical Center

Kirkland, Washington, 98034, United States

Location

University of Wisconsin Hospitals and Clinics

Madison, Wisconsin, 53705, United States

Location

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226-0509, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Dyskinesia, Drug-Induced; Dyskinesias

Interventions

6-fluoro-2-(4-(pyridin-2-yl)but-3-yn-1-yl)imidazo(1,2-a)pyridine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Neurotoxicity Syndromes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 23, 2021
• Study Start: August 6, 2021
• Primary Completion: June 17, 2022
• Study Completion: August 15, 2022
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (41)