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

Addex Therapeutics

Status and phase: Completed; Phase 2

Conditions: Blepharospasm; Dystonia

Treatments: Drug: Placebo; Drug: Dipraglurant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05027997

ADX48621-203

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Other protocol-defined inclusion and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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15 participants in 3 patient groups, including a placebo group

Dipraglurant 50 mg

Experimental group

Treatment:

Drug: Dipraglurant

Dipraglurant 100 mg

Experimental group

Treatment:

Drug: Dipraglurant

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo