Status:
RECRUITING
Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Revance Therapeutics, Inc.
Conditions:
Benign Essential Blepharospasm
Hemifacial Spasm
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to test the effects of DaxibotulinumtoxinA-Lanm (Daxxify) in patients with benign essential blepharospasms (BEB) and hemifacial spasms (HFS). The main questions to a...
Detailed Description
This will be a single-arm, crossover study, in which each patient is their own historical control using a 2:1 conversion ratio of Daxxify to Botox units. Study participants will be selected through th...
Eligibility Criteria
Inclusion
- Benign essential blepharospasm (BEB) or hemifacial spasm (HFS) as diagnosed by an ophthalmologist.
- No known neurologic or neuromuscular systematic medications.
- No history or surgical intervention for BEB or HFS.
Exclusion
- Patients will be excluded if age \< 18, are pregnant, non-willing, or with contra-indications to botulinum toxin.
Key Trial Info
Start Date :
February 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06195241
Start Date
February 11 2025
End Date
March 1 2027
Last Update
April 9 2025
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10466