Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-11

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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This will be a single-arm, crossover study, in which each patient is their own historical control using a 2:1 conversion ratio of Daxxify to Botox units. Study participants will be selected through the electronic medical records of ophthalmologists at Montefiore Medical Center. Medical documentation on each patient will include information on age, sex, race, Benign Essential Blepharospasm (BEB) diagnosis year and duration, Hemifacial Spasms (HFS) diagnosis year and duration, and past treatments.

The immediate effects (desired or undesired) of Daxxify observed within 48-72 hours, will be defined as (1) complete relief of spasms (2) partial relief to a tolerable level (3) mild to moderate ocular irritation (4) ptosis.

Overall efficacy will be evaluated using the base to peak efficacy (recorded in changes to Jankovic Rating Scale (JRS) scores) and be defined as (1) excellent (resolution of signs and symptoms, only requiring injections \> 5-6 months (2) moderate (improvement in signs and symptoms but requiring repeated injections within \< 5 months (3) poor (no improvement in signs and symptoms).

Adverse side effects will be documented, and Daxxify will be discontinued in any patients who develop significant side effects that outweigh the benefits.

Conditions

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Benign Essential Blepharospasm Hemifacial Spasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This will be a single-arm, crossover study, in which each patient is his/her own historical control using a 2:1 conversion ratio of Daxxify to Botox units.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Benign Essential Blepharospasm or Hemifacial Spasm

Patients with either Benign Essential Blepharospasms or Hemifacial Spasms

Group Type EXPERIMENTAL

DaxibotulinumtoxinA

Intervention Type DRUG

Patients with Benign Essential Blepharospasm (BEB) or Hemifacial spasms (HFS) will be treated with DaxibotulinumtoxinA-Lanm (Daxxify) using a 2:1 conversion rate of Daxxify to Botox.

Interventions

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DaxibotulinumtoxinA

Patients with Benign Essential Blepharospasm (BEB) or Hemifacial spasms (HFS) will be treated with DaxibotulinumtoxinA-Lanm (Daxxify) using a 2:1 conversion rate of Daxxify to Botox.

Intervention Type DRUG

Other Intervention Names

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Daxxify

Eligibility Criteria

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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.