Recruiting

DaxibotulinumtoxinA

Sponsor:

Montefiore Medical Center

Code:

NCT06195241

Conditions

Benign Essential Blepharospasm

Hemifacial Spasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DaxibotulinumtoxinA

Study Details

Brief 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.

Conditions

Benign Essential Blepharospasm

Hemifacial Spasm

Study ID

NCT06195241

Start date

Feb 11, 2025

Status verified date

Apr, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Benign Essential Blepharospasm or Hemifacial Spasm

Patients with either Benign Essential Blepharospasms or Hemifacial Spasms in accordance with Eligibility criteria.

Interventions

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 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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Isaac M Weber, BA

347-706-0146moshe.weber@einsteinmed.edu

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10466

Contacts

Anne Barmettler, MD

978-886-7122abarmett@montefiore.org

Isaac M Weber, BA

moshe.weber@einsteinmed.edu

More Information

Sponsor

Montefiore Medical Center

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-04-23.