Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm

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.

Timeline

Start

2025-02-11

Primary completion

2027-03

Completion

2027-03

Publications

• Background Anwar MS, Zafar H. Efficacy of botulinum toxin in benign essential Blepharospasm: Desirable & undesirable effects. Pak J Med Sci. 2013 Nov;29(6):1389-93. doi: 10.12669/pjms.296.3853.
• Background Carruthers JD, Fagien S, Joseph JH, Humphrey SD, Biesman BS, Gallagher CJ, Liu Y, Rubio RG; SAKURA 1 and SAKURA 2 Investigator Group; SAKURA 1 and SAKURA 2 Investigator Group includes the following. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2). Plast Reconstr Surg. 2020 Jan;145(1):45-58. doi: 10.1097/PRS.0000000000006327.
• Background Dutton JJ, Fowler AM. Botulinum toxin in ophthalmology. Surv Ophthalmol. 2007 Jan-Feb;52(1):13-31. doi: 10.1016/j.survophthal.2006.10.003.
• Background Hellman A, Torres-Russotto D. Botulinum toxin in the management of blepharospasm: current evidence and recent developments. Ther Adv Neurol Disord. 2015 Mar;8(2):82-91. doi: 10.1177/1756285614557475.
• Background Okumus S, Coskun E, Erbagci I, Tatar MG, Comez A, Kaydu E, Yayuspayi R, Gurler B. Botulinum toxin injections for blepharospasm prior to ocular surgeries. Clin Ophthalmol. 2012;6:579-83. doi: 10.2147/OPTH.S30277. Epub 2012 May 3.
• Background Solish N, Carruthers J, Kaufman J, Rubio RG, Gross TM, Gallagher CJ. Overview of DaxibotulinumtoxinA for Injection: A Novel Formulation of Botulinum Toxin Type A. Drugs. 2021 Dec;81(18):2091-2101. doi: 10.1007/s40265-021-01631-w. Epub 2021 Nov 17.
• Background Tambasco N, Filidei M, Nigro P, Parnetti L, Simoni S. Botulinum Toxin for the Treatment of Hemifacial Spasm: An Update on Clinical Studies. Toxins (Basel). 2021 Dec 9;13(12):881. doi: 10.3390/toxins13120881.
• Background Wabbels B, Yaqubi A. Validation of a new hemifacial spasm grading questionnaire (HFS score) assessing clinical and quality of life parameters. J Neural Transm (Vienna). 2021 Jun;128(6):793-802. doi: 10.1007/s00702-021-02343-x. Epub 2021 May 8.
• Background Bellows S, Jankovic J. Immunogenicity Associated with Botulinum Toxin Treatment. Toxins (Basel). 2019 Aug 26;11(9):491. doi: 10.3390/toxins11090491.

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Indications