Exploratory Study of Dipraglurant (ADX48621) for the Treatment of Patients With Blepharospasm
NCT ID: NCT05027997
Last Updated: 2025-10-03
Study Results
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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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
2021-10-06
2022-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dipraglurant 50 mg
Dipraglurant
Oral tablet
Dipraglurant 100 mg
Dipraglurant
Oral tablet
Placebo
Placebo
Oral matching placebo tablet
Interventions
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Dipraglurant
Oral tablet
Placebo
Oral matching placebo tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Addex Pharma S.A.
INDUSTRY
Responsible Party
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Locations
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Emory University
Atlanta, Georgia, United States
Countries
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Other Identifiers
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ADX48621-203
Identifier Type: -
Identifier Source: org_study_id
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