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Title: Prophylactic botulinum type A toxin complex (Dysport®) for migraine without aura
Authors: Siwaporn Chankrachang
Arkhom Arayawichanont
Niphon Poungvarin
Samart Nidhinandana
Pairoj Boonkongchuen
Somchai Towanabut
Pasiri Sithinamsuwan
Subsai Kongsaengdao
Chiang Mai University
Sappasitthiprasong Hospital
Mahidol University
Pramongkutklao Hospital
Bhumipol Adulyadej Hospital
Prasat Neurological Institute
Rajavithi Hospital
Rangsit University
Keywords: Medicine;Neuroscience
Issue Date: 1-Jan-2011
Citation: Headache. Vol.51, No.1 (2011), 52-63
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.
ISSN: 15264610
Appears in Collections:Scopus 2011-2015

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