A Phase 2 interventional study of Dipraglurant and Placebo in Blepharospasm and Dystonia, sponsored by Addex Pharma S.A.. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Addex Pharma S.A. · Phase 2, Interventional, and Treatment
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.
42 studies on the registry are indexed under Blepharospasm; 1 is open to participants now.
This study's enrollment of 15 is below the median of 40 across 28 interventional studies indexed under Blepharospasm.
Browse Blepharospasm studies →Addex Pharma S.A. is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria may apply
Drug: Dipraglurant
Drug: Dipraglurant
Drug: Placebo
Oral tablet
Also known as: ADX48621
Oral matching placebo tablet
Safety and tolerability of dipraglurant as measured by incidence of adverse events
The primary outcome will be testing the safety and tolerability of dipraglurant in patients with blepharospasm based on the incidence of adverse events reported by patients and/or as identified by the Investigator based on clinical assessments conducted during the study.
Time frame: Baseline to Day 2
Computerized Motor Objective Rater (CMOR) analysis of blinking activity
Video analysis, by an independent rater, of the mean proportion of eye closure time, severity of periocular spasms, and blink rate. Decreased eye closure time, severity of periocular spasms and blink rate indicates improvement of blepharospasm symptoms.
Time frame: Baseline to Day 2
Skintronics wearable analysis of blinking activity
Analysis of blinking activity as recorded on the Skintronics wearable device. Decreased blink activity indicates improvement of blepharospasm symptoms.
Time frame: Baseline to Day 2
Jankovic Rating Scale (JRS) severity score
The JRS is a clinician rated scale for blepharospasm. The intensity of eyelid spasms is measured based on a 5 point grading system where 0 indicates no symptoms and 4 indicates the most severe symptoms.
Time frame: Baseline to Day 2
Jankovic Rating Scale (JRS) frequency score
The JRS is a clinician rated scale for blepharospasm. The frequency of eyelid spasms is measured based on a 5 point grading system where 0 indicates no symptoms and 4 indicates highest frequency symptoms.
Time frame: Baseline to Day 2
Global Dystonia Severity Rating Scale (GDS)
The GDS is a clinician rated scale for the assessment of dystonia severity across multiple body regions. Each body region is rated on a scale from 0-10 where 0 represents no dystonia and 10 represents severe dystonia.
Time frame: Baseline to Day 2
Blepharospasm Phenotyping Tool (BPT)
The BPT is a clinician rated scale assessing 4 major phenotypic elements of blepharospasm using a 4 point scale for severity and frequency, where 0 indicates no symptoms and 4 indicates the highest frequency and/or most severe symptoms.
Time frame: Baseline to Day 2
Blepharospasm Severity Rating Scale (BSRS)
The BSRS is a clinician rated scale for rating severity of blepharospasm based on 6 clinical features of the condition. A total score is generated based on the combined score for severity and frequency and where a higher value indicates more severe symptoms.
Time frame: Baseline to Day 2
Clinician's Global Impression of Severity (CGI-S) score
The CGI-S score is used by the Investigator to determine, in a global sense, how severe the patients blepharospasm is in the context of other blepharospasm patients. Increased scores indicate more severe symptoms.
Time frame: Baseline to Day 2
Blepharospasm Disability Index (BSDI)
The BSDI is a 6 item patient rated disability scale that measures how blepharospasm effects activities of daily living. Each item is scored on a 5 point scale to produce a total score of up to 30, where a higher individual item score and a higher total score indicate greater disability to the patient.
Time frame: Baseline to Day 2
Patient Global Impression of Change (PGI-C) score
The PGI-C score is a patient reported outcome that assesses how much the blepharospasm symptoms have improved or worsened. A score of 0 indicates no change, negative scores down to -3 indicate worsening, and positive scores of up to 3 indicate improvement.
Time frame: Baseline to Day 2
Plan to share: No
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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dipraglurant
Addex Pharma S.A.