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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Addex Pharma S.A.

Criteria

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