drugset / Trial / NCT05027997
Exploratory Study of Dipraglurant (ADX48621) for the Treatment of Patients With Blepharospasm
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dipraglurant | Small molecule | 50 mg | Oral |
| Subject | Dipraglurant | Small molecule | 100 mg | Oral |