NCT05027997

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

Exploratory Phase 2a Randomized, Double-blind, Placebo-controlled Study of Dipraglurant (ADX48621) Immediate Release Tablets in Patients With Blepharospasm

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Addex Pharma S.A. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blepharospasm
• Dystonia

Interventions

Type	Name	Description
DRUG	Dipraglurant	Oral tablet
DRUG	Placebo	Oral matching placebo tablet

Timeline

• Start date: 2021-10-06
• Primary completion: 2022-10-27
• Completion: 2022-11-27
• First posted: 2021-08-31
• Last updated: 2025-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study