Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Patients will be excluded if age < 18, are pregnant, are non-willing, or have contra-indications to botulinum toxin.
Trial design
Treatments tested in this trial
- DaxibotulinumtoxinA
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Montefiore Medical Center
Lead sponsor
Revance Therapeutics, Inc.
Collaborator
Source ClinicalTrials.gov