Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy

NCT05116813 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: ADX48621-302
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Parkinson Disease; Dyskinesia, Drug-Induced; Dyskinesias

Keywords

Parkinson's disease; Dyskinesia; Levodopa-induced Dyskinesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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).

  Baseline (Day 1) to Week 52

Study Arms (1)

Dipraglurant TID

EXPERIMENTAL

Drug: Dipraglurant

Interventions

Dipraglurant DRUG

Oral 50 mg and 100 mg tablet

Also known as: ADX48621

Dipraglurant 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:

• Completed an Addex randomized controlled study of dipraglurant and, in the judgement of the Investigator, may benefit from open-label treatment
• Able to take study drug 3 times daily and no less than 3 hours apart
• Must be taking levodopa not less than 3 times daily throughout the study
• Must maintain stable regimen of antiparkinson's medications (including levodopa) and be willing to continue the same doses and regimens for the first 4 weeks of the study

You may not qualify if:

• Patient is judged by the Investigator to be inappropriate for the study (for reasons such as, but not limited to, significant noncompliance in the Addex randomized controlled study of dipraglurant)
• Use of amantadine or amantadine ER throughout the study
• Use of memantine throughout the study
• Any use of marijuana or other cannabis/cannabinoid products for the first 4 weeks of study participation

Sponsors & Collaborators

• Addex Pharma S.A.: lead

Study Sites (7)

Augusta University

Augusta, Georgia, 30912, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Rutgers, the State University of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210-1267, United States

Location

Abington Neurologic Associates

Abington, Pennsylvania, 19001-3816, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 11, 2021
• Study Start: October 25, 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 (7)