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Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary endpoint(s) modified
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 3 of 3 entries
    v12
  2. Primary endpoints: 4 to 1
    • Secondary endpoints: 9 to 3
    • Site contact updated
    v11
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2025 to Feb 11, 2025
    v10
  4. Primary and study completion dates: Jan 2027 to Mar 2027
    • Start date: Jan 2025 to Mar 2025
    v9
  5. Start date: Nov 2024 to Jan 2025v8 Show 4 more changesShow less
    • Primary endpoints: 3 to 4
    • Primary and study completion dates: Nov 2026 to Jan 2027
    • Secondary endpoints: 5 to 9
    • Collaborators expanded, about 3 words
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Sep 2024 to Nov 2024
    • Primary and study completion dates: Sep 2026 to Nov 2026
    v7
  2. Start date: Jul 2024 to Sep 2024
    • Primary and study completion dates: Jul 2026 to Sep 2026
    v6
  3. Start date: May 2024 to Jul 2024
    • Primary and study completion dates: May 2026 to Jul 2026
    v5
  4. Primary and study completion dates: Apr 2026 to May 2026
    • Start date: Apr 2024 to May 2024
    v4
  5. Primary completion date: Jul 2025 to Apr 2026
    • Start date: Feb 2024 to Apr 2024
    • Study completion date: Feb 2026 to Apr 2026
    v3
  6. Secondary endpoints: details revised at 1 of 5 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06195241
Lead Sponsor Montefiore Medical Center
Collaborators: Revance Therapeutics, Inc.
Conditions
(from sponsor)		 Benign Essential Blepharospasm, Hemifacial Spasm
Related terms Benign essential blepharospasm, Hemifacial Spasm
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov