Τίτλος:
IncobotulinumtoxinA for the Treatment of Blepharospasm in Toxin-Naïve Subjects: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial
Περίληψη:
This study aimed to assess the efficacy/safety of incobotulinumtoxinA (Xeomin®, Merz Pharmaceuticals GmbH) in botulinum neurotoxin-naïve subjects with blepharospasm. Botulinum neurotoxin-naïve subjects (≥ 12 months without botulinum neurotoxin treatment for blepharospasm) received single-dose incobotulinumtoxinA 50 U, 25 U, or placebo. Subjects were followed for 6–20 weeks (main period). Qualified subjects entered an open-label extension period and received another incobotulinumtoxinA injection (≤ 70 U). The primary efficacy variable was change from baseline in the Jankovic Rating Scale (JRS) severity subscore at the main period of week 6. Other efficacy variables included changes in the Blepharospasm Disability Index score and JRS frequency subscore and sumscore. Adverse events were monitored. Sixty-one subjects were randomized (main period: incobotulinumtoxinA 50 U, n = 19; incobotulinumtoxinA 25 U, n = 22; placebo, n = 20); 39 entered the open-label extension period (9, 14, and 16 subjects from the incobotulinumtoxinA 50 U, incobotulinumtoxinA 25 U, and placebo groups [main period], respectively, changed to open-label extension period dosing). A statistically significantly greater reduction in JRS severity subscore was reported for subjects receiving incobotulinumtoxinA 50 U versus placebo (ANCOVA, least square mean difference: − 1.2, p = 0.0004). Subjects receiving incobotulinumtoxinA experienced improvements in other efficacy variables versus baseline and/or placebo. Sustained clinical improvements and low adverse event rates (22.2–42.1%) were observed. This is the second placebo-controlled, double-blind study that demonstrates favorable efficacy/safety of incobotulinumtoxinA in subjects with blepharospasm. IncobotulinumtoxinA is the first botulinum neurotoxin that could fulfill the American Academy of Neurology criteria for a Level A recommendation for blepharospasm. Trial registration ClinicalTrials.gov identifier, NCT01896895. © 2020, Springer Healthcare Ltd., part of Springer Nature.
Συγγραφείς:
Mitsikostas, D.D.
Dekundy, A.
Sternberg, K.
Althaus, M.
Pagan, F.
Λέξεις-κλειδιά:
botulinum toxin A; placebo; botulinum toxin A; muscle relaxant agent, acute heart infarction; adult; aged; Article; blepharospasm; controlled study; disease severity assessment; double blind procedure; drug efficacy; drug safety; female; follow up; goiter; human; least square analysis; major clinical study; male; multicenter study; randomized controlled trial; rating scale; side effect; single drug dose; statistical significance; clinical trial; treatment outcome, Blepharospasm; Botulinum Toxins, Type A; Double-Blind Method; Humans; Neuromuscular Agents; Treatment Outcome
