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

Phase 2

• Conditions: Dyskinesia, Drug-Induced; Parkinson Disease; Dyskinesias
• Interventions: Drug: Dipraglurant

• Registration Number: NCT05116813
• Lead Sponsor: Addex Pharma S.A.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-25
• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-11
• Status Verified: 2022-02
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-25
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dipraglurant TID	Dipraglurant	-

Primary Outcome Measures

Name	Time	Method
Long-term safety and tolerability of dipraglurant as measured by incidence of adverse events	Baseline (Day 1) to Week 52	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.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (7)

Abington Neurologic Associates; 🇺🇸 Abington, Pennsylvania, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Rutgers, the State University of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

Augusta University; 🇺🇸 Augusta, Georgia, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States