title: Prophylactic botulinum type A toxin complex (Dysport®) for migraine without aura.
abstract: OBJECTIVE
  To evaluate the efficacy, safety, and optimum dose of a highly purified Clostridium botulinum type A toxin-hemagglutinin complex (Dysport) for migraine prophylaxis.
  
  
  BACKGROUND
  Botulinum toxin type-A has demonstrated good efficacy in several open-label studies of patients with migraine, involving either individualized or standardized protocols, although data from placebo-controlled trials have been conflicting.
  
  
  METHODS
  A 12-week, double-blind, randomized trial of Dysport (120 or 240 units) vs placebo was conducted in 6 centers in Thailand to evaluate the efficacy, safety, and optimum dose of botulinum toxin type-A (Dysport) for migraine prophylaxis. A total of 128 patients with migraine without aura were enrolled. The primary end point was the change in the mean number of migraine attacks per 4-week period from the pre-treatment period to 8-12 weeks post injection. Secondary efficacy measures included the change in the mean total intensity score from the pre-treatment period to 8-12 weeks, the investigator and patient global assessments of change at each visit compared with pre-treatment, and Migraine Disability Assessment and Short Form-36 scores.
  
  
  RESULTS
  Change in number of migraine attacks from pre-treatment to weeks 8-12 was not significantly different. There was a greater improvement in total intensity score at weeks 8-12 with Dysport-240 (not significant), and interim visit data showed that this was significant at weeks 0-4 (P = .03 Dysport-240 vs placebo). The mean duration of headache during weeks 0-4 was lower with Dysport-240 (P = .04 vs placebo). Improvements in patient and investigator global assessments of change between weeks 0-4 and 8-12 were significant for the Dysport-240 group (both P < .05 vs placebo).
  
  
  CONCLUSIONS
  Limitations in study design and assessment tools employed may have contributed to the inconclusive nature of the primary end point data. Dysport-240 showed significant benefit over placebo at some end points and further trials with more appropriate outcome measures are required to evaluate effectively this treatment.
authors.affiliation: Division of Neurology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
authors.forename: Siwaporn
authors.initials: S
authors.lastname: Chankrachang
authors.forename: Arkhom
authors.initials: A
authors.lastname: Arayawichanont
authors.forename: Niphon
authors.initials: N
authors.lastname: Poungvarin
authors.forename: Samart
authors.initials: S
authors.lastname: Nidhinandana
authors.forename: Pairoj
authors.initials: P
authors.lastname: Boonkongchuen
authors.forename: Somchai
authors.initials: S
authors.lastname: Towanabut
authors.forename: Pasiri
authors.initials: P
authors.lastname: Sithinamsuwan
authors.forename: Subsai
authors.initials: S
authors.lastname: Kongsaengdao
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020326:Migraine without Aura / Q000188:drug therapy*; D009465:Neuromuscular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A