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

NCT05027997 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-10-03

No results posted yet for this study

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

DRUG

Dipraglurant

Oral tablet

DRUG

Placebo

Oral matching placebo tablet

Sponsors & Collaborators

  • Addex Pharma S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2022-10-27
Completion
2022-11-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05027997 on ClinicalTrials.gov