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

Parkinson Disease Clinical Trial

Official title:

An Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy With or Without Concomitant Dopaminergic Medications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05116813
• Other study ID #: ADX48621-302
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 25, 2021
• Est. completion date: December 2023

Study information

• Verified date: February 2022
• Source: Addex Pharma S.A.
• Contact: Study Director
• Phone: 877-409-1775
• Email: addex[@]druginfo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyskinesia, Drug-Induced
• Dyskinesias
• Parkinson Disease

Intervention

Drug:
• Dipraglurant
Oral 50 mg and 100 mg tablet

Locations

Country	Name	City	State
United States	Abington Neurologic Associates	Abington	Pennsylvania
United States	Augusta University	Augusta	Georgia
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
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	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Addex Pharma S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline (Day 1) to Week 52