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NCT06195241 · ClinicalTrials.gov registry record · Phase 4
Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm
A Phase 4 study of Benign Essential Blepharospasm and Hemifacial Spasm, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06195241: Recruiting Phase 4 study of Benign Essential Blepharospasm and Hemifacial Spasm, sponsored by Montefiore Medical Center.
NCT06195241 is a Phase 4 study of Benign Essential Blepharospasm and Hemifacial Spasm that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06195241, a Phase 4 study of Benign Essential Blepharospasm and Hemifacial Spasm, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 s
Conditions Studied
Interventions
- DRUG DaxibotulinumtoxinA
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-02-11 |
| Est. Completion | 2027-03 |
| Phase | Phase 4 |
What NCT06195241 shows while recruiting
NCT06195241 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Benign Essential Blepharospasm appearing as the primary indexed condition, and to 1 intervention - of which DaxibotulinumtoxinA is the first listed.
NCT06195241 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06195241 about?
NCT06195241 is a clinical study titled "Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm". 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...
What is the current status of trial NCT06195241?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2025-02-11. Estimated completion is 2027-03.
What conditions does trial NCT06195241 study?
This clinical trial studies the following conditions: Benign Essential Blepharospasm, Hemifacial Spasm.
What interventions are being tested in trial NCT06195241?
The interventions under investigation include: DaxibotulinumtoxinA (DRUG).
Who is sponsoring clinical trial NCT06195241?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06195241 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06195241's enrollment target sits among peer trials
40 1397th of 2000 higher than 534 of 2,000 other Phase 4 trials
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Source ClinicalTrials.gov registry export · 2026-08-08
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