drugset / Trial / NCT05027997

Exploratory Study of Dipraglurant (ADX48621) for the Treatment of Patients With Blepharospasm

NCT05027997 ↗

Phase 2 Completed 15 enrolled Addex Pharma S.A.
RandomizedParallel-groupTriple-blindTreatment

Summary

This study is designed to assess the safety and tolerability of dipraglurant in patients with blepharospasm (BSP) (randomized 1:1:1 to receive dipraglurant 50 mg, 100 mg or placebo) and explore the efficacy of 50 mg and 100 mg immediate release tablets (versus placebo) on the severity and frequency of BSP signs and symptoms using objective measures, clinical ratings and patient reported outcomes.

Timeline

Start
2021-10-06
Primary completion
2022-10-27
Completion
2022-11-27

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

release “outcome of a small Phase 2a feasibility study of dipraglurant in patients with blepharospasm was inconclusive” addextherapeutics.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dipraglurant Small molecule 50 mg Oral
Subject Dipraglurant Small molecule 100 mg Oral