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

NCT ID: NCT05027997

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-06

Study Completion Date

2022-11-27

Brief Summary

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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.

Detailed Description

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Conditions

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Blepharospasm Dystonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dipraglurant 50 mg

Group Type EXPERIMENTAL

Dipraglurant

Intervention Type DRUG

Oral tablet

Dipraglurant 100 mg

Group Type EXPERIMENTAL

Dipraglurant

Intervention Type DRUG

Oral tablet

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral matching placebo tablet

Interventions

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Dipraglurant

Oral tablet

Intervention Type DRUG

Placebo

Oral matching placebo tablet

Intervention Type DRUG

Other Intervention Names

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ADX48621

Eligibility Criteria

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Inclusion Criteria

* Patients with an established diagnosis of idiopathic benign essential blepharospasm
* Must have had prior response to to botulinum toxin (BoNT) reported on last 2 consecutive injection cycles
* Last injection of BoNT at least 8 weeks prior to Screening assessments
* Patient is experiencing features of Blepharospasm (BSP) of moderate severity/frequency at study entry.

Exclusion Criteria

* BSP that is known or suspected to be associated with a known cause such as neuroleptic exposure, brain injury or lesion, stroke, Parkinson's disease, or related Parkinsonisms
* History of surgical intervention (e.g., deep brain stimulation) or orbital myectomy for dystonia
* Disabling eyelid opening apraxia
* Other neurological disease (including psychiatric disease and/or cognitive impairment) that, in the opinion of the investigator, would affect the patient's ability to complete study assessments.
* Other significant medical condition that may affect the safety of the patient or preclude adequate participation in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Addex Pharma S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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ADX48621-203

Identifier Type: -

Identifier Source: org_study_id

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