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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Montefiore Medical Center

The Bronx, New York, United States, 10466