RECRUITING

Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-11
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06195241

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Benign essential blepharospasm (BEB) or hemifacial spasm (HFS) as diagnosed by an ophthalmologist.
  2. * No known neurologic or neuromuscular systematic medications.
  3. * No history or surgical intervention for BEB or HFS.
  1. * Patients will be excluded if age \< 18, are pregnant, non-willing, or with contra-indications to botulinum toxin.

Contacts and Locations

Study Contact

Ricky Paramo, BS
CONTACT
718-920-2020
rickyparamo@gmail.com

Principal Investigator

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

Study Locations (Sites)

Montefiore Medical Center
Bronx, New York, 10466
United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-11
Study Completion Date2027-03

Study Record Updates

Study Start Date2025-02-11
Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

  • Benign Essential Blepharospasm
  • Hemifacial Spasm