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A multicentre, double-blind, randomized, placebo-controlled, parallel group study of multiple treatments of botulinum toxin type A (BoNTA) for the prophylaxis of episodic migraine headaches.
Cephalalgia. 2007 Jun; 27(6):492-503.C

Abstract

Our aim was to evaluate the safety and efficacy of botulinum toxin type A (BoNTA; BOTOX) for prophylaxis of episodic migraine. In this double-blind, placebo-controlled study, patients were randomized to 225, 150 or 75 U of BoNTA or placebo after a 30-day placebo run-in for three 90-day treatment cycles. The primary efficacy end-point was the mean reduction from baseline in the frequency of migraine episodes at day 180 in the placebo non-responder stratum. All groups (N = 495) improved, with no significant differences. At day 180, the frequency of migraine episodes was reduced from baseline means of 4.3, 4.7, 4.7 and 4.4 by 1.6, 1.7, 1.5 and 1.4 for BoNTA 225 U, 150 U and 75 U and placebo, respectively. The primary end-point was not met. Treatment-related adverse events were transient and mild to moderate. BoNTA treatment was safe and well tolerated but did not result in significantly greater improvement than placebo in this study. Several factors may have confounded the results.

Authors+Show Affiliations

Department of Neurology, Medical School University of Zagreb, Zagreb, Croatia. mrelja@mef.hrNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17428299

Citation

Relja, M, et al. "A Multicentre, Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Multiple Treatments of Botulinum Toxin Type a (BoNTA) for the Prophylaxis of Episodic Migraine Headaches." Cephalalgia : an International Journal of Headache, vol. 27, no. 6, 2007, pp. 492-503.
Relja M, Poole AC, Schoenen J, et al. A multicentre, double-blind, randomized, placebo-controlled, parallel group study of multiple treatments of botulinum toxin type A (BoNTA) for the prophylaxis of episodic migraine headaches. Cephalalgia. 2007;27(6):492-503.
Relja, M., Poole, A. C., Schoenen, J., Pascual, J., Lei, X., & Thompson, C. (2007). A multicentre, double-blind, randomized, placebo-controlled, parallel group study of multiple treatments of botulinum toxin type A (BoNTA) for the prophylaxis of episodic migraine headaches. Cephalalgia : an International Journal of Headache, 27(6), 492-503.
Relja M, et al. A Multicentre, Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Multiple Treatments of Botulinum Toxin Type a (BoNTA) for the Prophylaxis of Episodic Migraine Headaches. Cephalalgia. 2007;27(6):492-503. PubMed PMID: 17428299.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicentre, double-blind, randomized, placebo-controlled, parallel group study of multiple treatments of botulinum toxin type A (BoNTA) for the prophylaxis of episodic migraine headaches. AU - Relja,M, AU - Poole,A C, AU - Schoenen,J, AU - Pascual,J, AU - Lei,X, AU - Thompson,C, AU - ,, Y1 - 2007/04/11/ PY - 2007/4/13/pubmed PY - 2007/9/27/medline PY - 2007/4/13/entrez SP - 492 EP - 503 JF - Cephalalgia : an international journal of headache JO - Cephalalgia VL - 27 IS - 6 N2 - Our aim was to evaluate the safety and efficacy of botulinum toxin type A (BoNTA; BOTOX) for prophylaxis of episodic migraine. In this double-blind, placebo-controlled study, patients were randomized to 225, 150 or 75 U of BoNTA or placebo after a 30-day placebo run-in for three 90-day treatment cycles. The primary efficacy end-point was the mean reduction from baseline in the frequency of migraine episodes at day 180 in the placebo non-responder stratum. All groups (N = 495) improved, with no significant differences. At day 180, the frequency of migraine episodes was reduced from baseline means of 4.3, 4.7, 4.7 and 4.4 by 1.6, 1.7, 1.5 and 1.4 for BoNTA 225 U, 150 U and 75 U and placebo, respectively. The primary end-point was not met. Treatment-related adverse events were transient and mild to moderate. BoNTA treatment was safe and well tolerated but did not result in significantly greater improvement than placebo in this study. Several factors may have confounded the results. SN - 0333-1024 UR - https://www.unboundmedicine.com/medline/citation/17428299/A_multicentre_double_blind_randomized_placebo_controlled_parallel_group_study_of_multiple_treatments_of_botulinum_toxin_type_A__BoNTA__for_the_prophylaxis_of_episodic_migraine_headaches_ L2 - http://journals.sagepub.com/doi/full/10.1111/j.1468-2982.2007.01315.x?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -