NCT04857359

Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy

Phase 2b/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Dipraglurant (ADX48621) for the Treatment of Dyskinesia in Patients With Parkinson's Disease Receiving Levodopa-based Therapy

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Addex Pharma S.A. · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day). The primary efficacy assessment will be based on the Unified Dyskinesia Rating Scale (UDysRS). Patients who complete the 12-week blinded treatment period may have the option to roll into an open-label safety extension study for an additional 12-month treatment period.

Conditions

• Parkinson Disease
• Dyskinesia, Drug-Induced
• Dyskinesias

Interventions

Type	Name	Description
DRUG	Dipraglurant	Oral 50mg and 100mg tablet
DRUG	Placebo	Oral matching placebo tablet

Timeline

• Start date: 2021-08-06
• Primary completion: 2022-06-17
• Completion: 2022-08-15
• First posted: 2021-04-23
• Last updated: 2025-08-06

Locations

41 sites across 1 country: United States

Regulatory

• FDA-regulated drug study