NCT05116813

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

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Addex Pharma S.A. · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Dipraglurant	Oral 50 mg and 100 mg tablet

Timeline

• Start date: 2021-10-25
• Primary completion: 2022-06-17
• Completion: 2022-08-15
• First posted: 2021-11-11
• Last updated: 2025-08-06

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study