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

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.

Timeline

Start

2021-08-06

Primary completion

2022-06-17

Completion

2022-08-15

Outcome

Outcome not reported

Stopped (Enrollment): “Terminated prior to completing enrollment goals due to COVID-related difficulties in recruiting patients”

Drugs

Indications