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

Phase 3TerminatedNCT05116813

Addex Pharma S.A.17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease Dyskinesia, Drug-Induced Dyskinesias

Interventions

DipraglurantDRUG

Oral 50 mg and 100 mg tablet

Eligibility

Sex: ALLMin age: 30 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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 Other protocol-defined inclusion and exclusion criteria may apply

Locations (7)

Augusta University

Augusta, Georgia, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Rutgers, the State University of New Jersey

New Brunswick, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline (Day 1) to Week 52

Secondary Outcomes

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).

The MDS-UPDRS is a Parkinson's Disease (PD) rating scale scored from 0-272; it evaluates progression of disease in patients with PD. A higher score indicates more severe PD.

Time frame: Baseline (Day 1) to Week 52

Data from ClinicalTrials.gov

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