Botulinum toxin type B (Myobloc®) in subjects with hemifacial spasm: Results from an open-label, dose-escalation safety study

Richard M. Trosch, Charles H. Adler, Eric J. Pappert

Research output: Contribution to journalArticle

7 Scopus citations

Abstract

Ojbective: Evaluate the safety of botulinum toxin type B (BoNT-B) in subjects with hemifacial spasm (HFS). Methods: This open-label, sequential dose-escalation study evaluated BoNT-B in subjects with HFS. Eligible subjects were enrolled and received a single injection of one of four sequential BoNT-B doses (100, 200, 400, or 800 U). Following injection, subjects were evaluated in person at Weeks 2 and 8 and by phone at Weeks 1, 4, and 10 and every 2 weeks thereafter until benefit was lost. Safety was assessed by adverse events (AEs), vital signs and clinical laboratory evaluation. The severity of HFS was assessed using a patient social impairment visual analog scale (VAS), subject severity of contraction VAS, the HFS physician assessment, and subject HFS frequency and severity assessment. Results: Nineteen predominately Caucasian (92%) and female (67%) subjects (aged 36-80 years) with HFS participated in this study. Subjects remained in the study an average of 88 days (range of 41-332 days) after receiving a single dose of BoNT-B. No deaths, serious AEs or AEs leading to trial discontinuation occurred during the study period. Two subjects in the 400 U dose group requested early withdrawal, whereas all other subjects completed the study. A reduction in HFS severity was observed in subjects treated with doses of 200 U or more. Improvements in subject HFS assessments tended to return to baseline values by 8 weeks following injection. Conclusion: BoNT-B was well-tolerated and reduced HFS severity in subjects who received injections of 200 to 800 U. Additional investigation is necessary to confirm the findings from this open-label study.

Original languageEnglish (US)
Pages (from-to)1258-1264
Number of pages7
JournalMovement Disorders
Volume22
Issue number9
DOIs
StatePublished - Jul 15 2007

Keywords

  • BoNT-B
  • Botulinum toxin type B
  • Hemifacial spasm
  • Myobloc

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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