The Safety and Efficacy of DaxibotulinumtoxinA-Lanm for Benign Essential Blepharospasm and Hemifacial Spasm

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 answer: 1. Is there clinically significant difference (measured by Jankovic Rating Scale (JRS) score from base to peak efficacy) for patients with BEB and HFS treated with Daxxify? 2. What percentage of patients achieve a clinical response? Participants historically treated with Botox for either BEB or HFS will be crossed over to Daxxify treatment in order to serve as their own control and examine the efficacy of Daxxify.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
Ricky Paramo, BS
rickyparamo@gmail.com
718-920-2020
Time Frame
Start Date: 2025-02-11
Estimated Completion Date: 2027-03
Participants
Target number of participants: 40
Treatments
Experimental: Benign Essential Blepharospasm or Hemifacial Spasm
Patients with either Benign Essential Blepharospasms or Hemifacial Spasms
Related Therapeutic Areas
Sponsors
Leads: Montefiore Medical Center
Collaborators: Revance Therapeutics, Inc.

This content was sourced from clinicaltrials.gov