DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm
This study is testing DaxibotulinumtoxinA (Daxxify) for people with benign essential blepharospasm (BEB) or hemifacial spasm (HFS). BEB causes uncontrollable blinking or eyelid spasms, and HFS causes involuntary muscle contractions on one side of the face. The goal is to see if Daxxify helps reduce these spasms and how well it works compared to past Botox treatments. You may be able to join if you are 18 or older, have BEB or HFS diagnosed by an eye doctor, and have not had surgery for these conditions. The study will measure success by looking at changes in your symptoms using a special rating scale. The study plans to enroll 40 participants, but its current status is unclear.
- Study design
- This is a single-arm study, meaning all participants will receive the study drug. Each participant will serve as their own comparison by switching from their historical Botox treatment to Daxxify.
- What's involved
- You will receive Daxxify injections. Your symptoms will be measured before treatment, then at 1 month, 3 months, and monthly after that until your symptoms are gone, for up to 9 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed monthly after 3 months post-treatment until symptoms are free, up to a maximum of 9 months.
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Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Anne Barmettler, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center/Albert Einstein College of Medicine
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Therapeutic Response based on the modified Jankovic Rating ScalePrior to treatment at beginning of study, 1 month post-treatment, 3 months post-treatment, and on a monthly basis after 3-month timepoint until symptom free, up to a maximum of 9 months
Therapeutic response of Daxxify will be measured as the significant difference between the baseline to peak efficacy scores using the modified Jankovic rating scale (JRS). The JRS scale is a validated physician rating scale that consists of two subscales: blepharospasm (or hemifacial spasm) severity and blepharospasm (or hemifacial spasm) frequency. Each subscale is based on a 5-point scale ranging from 0-4, where 0 indicates no symptoms or frequency and 4 indicates the most severe or frequent symptoms. Overall scores will be reported as the sum of the two subscales of severity and frequency of symptoms and will range from 0-8. The modified JRS will be modified slightly to include hemifacial spasm as opposed to just including blepharospasm. Basic descriptive statistics will be used to summarize and report therapeutic response. The Wilcoxon signed-ranked test will be used to analyze paired ordinal data gathered from the JRS scores.