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NCT Number: NCT06195241

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 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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Key information

Conditions

Benign Essential Blepharospasm Hemifacial Spasm Mouth Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DaxibotulinumtoxinA

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 units.

BEB dosing: participants will receive Daxxify at 10 sites using a 2:1 conversion ratio of Daxxify to Botox units. The location of these injections are in the superficial dermis in the sites typical for BEB.

HFS dosing: participants will then receive Daxxify at 8 sites using a 2:1 conversion ratio of Daxxify to Botox units. The location of these injections are in the superficial dermis in the sites typical for HFS.

Patients will be followed monthly to measure duration and efficacy of the Daxxify. Patients will receive their single dose of Daxxify at the same time point in which they would have normally received their next Botox treatment, without a washout period.

Other names: Daxxify

Primary outcomes

  1. Therapeutic Response based on the modified Jankovic Rating Scale

    Time frame: Prior 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.

Secondary outcomes

  1. Waning of Effect

    Time frame: 1 month post-treatment, 3 months post-treatment, and on a monthly basis after 3-month timepoint until symptoms return to baseline, up to a maximum of 9 months

    Waning of effect will be assessed by quantifying the patient-reported time, in months, to noticing a loss of peak treatment effect (i.e., start of waning). The number of months until noticing a loss of peak treatment effect will be summarized and reported using basic descriptive statistics.

  2. Loss of Efficacy

    Time frame: 1 month post-treatment, 3 months post-treatment, and on a monthly basis after 3-month timepoint until symptoms return to baseline, up to a maximum of 9 months

    Loss of efficacy will be assessed by quantifying the patient-reported time, in months, to noticing a complete loss of efficacy (return to baseline symptom status). The number of months to complete loss of efficacy will be summarized and reported using basic descriptive statistics.

  3. Incidence Rate of Treatment Failure

    Time frame: Up to four weeks post treatment

    Participant incidence rate of treatment failure will be measured as a lack of response or primary non-response (defined as a < 25% response from the first injection and subsequent injections of increasing dosages) to medication up to four weeks later for either benign essential blepharospasm or hemifacial spasm. Incidence rate of treatment failure will be defined as the percentage of participants who did not respond to treatment and will be summarized using basic descriptive statistics.

Study contacts

Contact information is provided by the study sponsor or research team.

Isaac M Weber, BA

CONTACT

[email protected]

347-706-0146

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Revance Therapeutics, Inc.

Registry information

Official study title

The Safety and Efficacy of DaxibotulinumtoxinA-Lanm for Benign Essential Blepharospasm and Hemifacial Spasm

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2024
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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