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

What this Trial Is About

Researchers are evaluating the effects of DaxibotulinumtoxinA-Lanm (Daxxify) in people with benign essential blepharospasm (BEB) and hemifacial spasms (HFS). This study aims to determine if there is a significant difference in symptom improvement compared to previous Botox treatment, using the Jankovic Rating Scale (JRS) to measure changes. Patients who have been treated with Botox will switch to Daxxify to serve as their own control in this single-arm crossover study. Participants will receive Daxxify injections using a 2:1 conversion ratio to Botox units. Those with BEB will receive Daxxify at 10 sites in the superficial dermis typical for BEB, while those with HFS will receive injections at 8 such sites. The dosing is scheduled to coincide with when they would normally get their next Botox treatment, with no washout period. Patients will be monitored monthly for up to nine months to track the duration and effectiveness of the treatment. During the study, researchers will assess therapeutic response based on changes in the modified Jankovic Rating Scale at various time points, including before treatment, and one, three, and monthly up to nine months after treatment. They will also document any side effects and discontinue treatment if adverse effects outweigh benefits. Additional evaluations include the waning of effect, loss of efficacy, and incidence of treatment failure. This ongoing monitoring ensures patient safety and comprehensive data collection throughout participation.

Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm