Testing DaxibotulinumtoxinA for treating eyelid and facial spasms
Official title: The Safety and Efficacy of DaxibotulinumtoxinA-Lanm for Benign Essential Blepharospasm and Hemifacial Spasm
Run by Montefiore Medical Center · NCT06195241 · Data updated 2026-11-12
This study is testing if a new treatment called DaxibotulinumtoxinA can help people with eyelid and facial spasms feel better compared to their previous Botox treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Status | Recruiting |
| Started | February 11, 2025 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT06195241 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults diagnosed with benign essential blepharospasm or hemifacial spasm who have not undergone prior surgical interventions for these conditions.
✕Probably not a fit
Patients under 18, pregnant individuals, or those with contraindications to botulinum toxin will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effects of DaxibotulinumtoxinA-Lanm (Daxxify) in patients suffering from benign essential blepharospasm (BEB) and hemifacial spasm (HFS). It employs a single-arm, crossover design where participants previously treated with Botox will switch to Daxxify, allowing for a direct comparison of efficacy using their own historical data. The study will assess the clinical response through the Jankovic Rating Scale (JRS) and monitor immediate effects within 48-72 hours post-treatment. Adverse effects will also be documented to ensure patient safety.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief from spasms for patients with BEB and HFS, improving their quality of life.
How similar studies have gone: Previous studies have shown positive outcomes with botulinum toxin treatments for similar conditions, suggesting potential success for this novel approach with DaxibotulinumtoxinA.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Montefiore Medical Center
The Bronx, New York, United States Recruiting
Study contacts
- Principal investigator: Anne Barmettler, MD — Montefiore Medical Center/Albert Einstein College of Medicine
- Study coordinator: Isaac M Weber, BA
- Email: moshe.weber@einsteinmed.edu
- Phone: 347-706-0146
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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DAXI for Blepharospasm in Adults
This study tests DaxibotulinumtoxinA (DAXI) to see how long it lasts and how safe it is for adults with blepharospasm who are already getting botulinum toxin injections.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.