Publication: Prophylactic botulinum type A toxin complex (Dysport®) for migraine without aura
Issued Date
2011-01-01
Resource Type
ISSN
15264610
00178748
00178748
Other identifier(s)
2-s2.0-78650945696
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Headache. Vol.51, No.1 (2011), 52-63
Suggested Citation
Siwaporn Chankrachang, Arkhom Arayawichanont, Niphon Poungvarin, Samart Nidhinandana, Pairoj Boonkongchuen, Somchai Towanabut, Pasiri Sithinamsuwan, Subsai Kongsaengdao Prophylactic botulinum type A toxin complex (Dysport®) for migraine without aura. Headache. Vol.51, No.1 (2011), 52-63. doi:10.1111/j.1526-4610.2010.01807.x Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/12779
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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. © 2010 American Headache Society.