Testing DaxibotulinumtoxinA for treating eyelid and facial spasms
The Safety and Efficacy of DaxibotulinumtoxinA-Lanm for Benign Essential Blepharospasm and Hemifacial Spasm
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 |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT06195241 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with benign essential blepharospasm or hemifacial spasm who have not undergone prior surgical interventions for these conditions.
Not a fit: Patients under 18, pregnant individuals, or those with contraindications to botulinum toxin will not benefit from this study.
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 performed: Previous studies have shown positive outcomes with botulinum toxin treatments for similar conditions, suggesting potential success for this novel approach with DaxibotulinumtoxinA.
Eligibility criteria
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 this trial is running
The Bronx, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.