Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm

Description

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

Study Overview

Study Details

Study overview

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.

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

Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm

Condition
Benign Essential Blepharospasm
Intervention / Treatment

-

Contacts and Locations

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10466

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Patients will be excluded if age \< 18, are pregnant, non-willing, or with contra-indications to botulinum toxin.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Montefiore Medical Center,

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

Study Record Dates

2027-03