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Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm

NCT06195241 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

  • Benign Essential Blepharospasm
  • Hemifacial Spasm

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 units. BEB dosing: participants will receive Daxxify at 10 sites using a 2:1 conversion ratio of Daxxify to Botox units. The location of these injections are in the superficial dermis in the sites typical for BEB. HFS dosing: participants will then receive Daxxify at 8 sites using a 2:1 conversion ratio of Daxxify to Botox units. The location of these injections are in the superficial dermis in the sites typical for HFS. Patients will be followed monthly to measure duration and efficacy of the Daxxify. Patients will receive their single dose of Daxxify at the same time point in which they would have normally received their next Botox treatment, without a washout period.

Sponsors & Collaborators

  • Revance Therapeutics, Inc.

    collaborator INDUSTRY

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Anne Barmettler, MD · Montefiore Medical Center/Albert Einstein College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-11
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06195241 on ClinicalTrials.gov