The Safety and Efficacy of DaxibotulinumtoxinA-Lanm for Benign Essential Blepharospasm and Hemifacial Spasm
Montefiore Medical Center
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.
Description
This will be a single-arm, crossover study, in which each patient is their own historical control using a 2:1 conversion ratio of Daxxify to Botox units. Study participants will be selected through the electronic medical records of ophthalmologists at Montefiore Medical Center. Medical documentation on each patient will include information on age, sex, race, Benign Essential Blepharospasm (BEB) diagnosis year and duration, Hemifacial Spasms (HFS) diagnosis year and duration, and past treatments. The immediate effects (desired or undesired) of Daxxify observed within 48-72 hours, will be defin…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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 are required to have a minimum score of 4 out of 8 on the modified Jankovic Rating Scale for Severity/Frequency. Exclusion Criteria: * Patients will be excluded if age \< 18, are pregnant, are non-willing, or have contra-indications to botulinum toxin.
Interventions
- DrugDaxibotulinumtoxinA
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.
Location
- Montefiore Medical CenterThe Bronx, New York