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RECRUITING
NCT06195241
PHASE4

Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm

Sponsor: Montefiore Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-02-11

Completion Date

2027-03

Last Updated

2025-04-09

Healthy Volunteers

Yes

Interventions

DRUG

DaxibotulinumtoxinA

Patients with Benign Essential Blepharospasm (BEB) or Hemifacial spasms (HFS) will be treated with DaxibotulinumtoxinA-Lanm (Daxxify) using a 2:1 conversion rate of Daxxify to Botox.

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States