Prophylactic Botulinum Type A Toxin Complex (Dysport®) for Migraine Without Aura
| Autor: | Arkhom Arayawichanont, Somchai Towanabut, Pasiri Sithinamsuwan, Subsai Kongsaengdao, Samart Nidhinandana, Pairoj Boonkongchuen, Niphon Poungvarin, Siwaporn Chankrachang |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Male Migraine without Aura Adolescent Endpoint Determination Clostridium botulinum type A Placebo law.invention Cohort Studies Young Adult Double-Blind Method Randomized controlled trial law Clinical endpoint medicine Humans Botulinum Toxins Type A Aged business.industry Middle Aged medicine.disease Botulinum toxin Clinical trial Treatment Outcome Neuromuscular Agents Neurology Migraine Anesthesia Female Neurology (clinical) business medicine.drug Cohort study |
| Zdroj: | Headache: The Journal of Head and Face Pain. 51:52-63 |
| ISSN: | 0017-8748 |
| Popis: | (Headache 2011;51:52-63) 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 |
| Databáze: | OpenAIRE |
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