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A series of three sequential, randomized, controlled studies of repeated treatments with botulinum toxin type A for migraine prophylaxis.
J Pain. 2006 Oct; 7(10):688-96.JP

Abstract

We examined the effects of multiple treatments with low doses of botulinum toxin type A (BoNTA; BOTOX(R), Allergan Inc., Irvine, CA) versus placebo for prophylaxis of episodic migraine. This was a series of 3 sequential, randomized, controlled studies of 418 patients with a history of 4 to 8 moderate to severe migraines per month. In study I, patients were randomized to treatment with placebo or BoNTA (7.5 U, 25 U, or 50 U) in predetermined fixed injection sites on the front and sides of the head only. In study II, patients continued to receive, or were randomized to, 2 consecutive treatments with 25 U or 50 U. In study III, patients were randomized to placebo or continuation of 25 U or 50 U. Injection cycles were each 4 months long. BoNTA and placebo produced comparable decreases from baseline in the frequency of migraines at each time point examined (P >or= .201). No consistent, statistically significant differences were observed for any efficacy variable. Adverse events were similar among the groups within each study. In these exploratory studies of episodic migraine patients, repeated injections of low doses of BoNTA into fixed frontal, temporal, and glabellar sites were not more effective than placebo. BoNTA was safe and well tolerated.

PERSPECTIVE

Beneficial effects of BoNTA in the treatment of migraine have been reported, but positive results are not universal, possibly because the optimal patient population and regimen are not yet definitively established. This study explores the effects of multiple injections of low BoNTA doses into fixed sites for episodic migraine.

Authors+Show Affiliations

Elkind Headache Center, Mount Vernon, New York, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17018329

Citation

Elkind, Arthur H., et al. "A Series of Three Sequential, Randomized, Controlled Studies of Repeated Treatments With Botulinum Toxin Type a for Migraine Prophylaxis." The Journal of Pain : Official Journal of the American Pain Society, vol. 7, no. 10, 2006, pp. 688-96.
Elkind AH, O'Carroll P, Blumenfeld A, et al. A series of three sequential, randomized, controlled studies of repeated treatments with botulinum toxin type A for migraine prophylaxis. J Pain. 2006;7(10):688-96.
Elkind, A. H., O'Carroll, P., Blumenfeld, A., DeGryse, R., & Dimitrova, R. (2006). A series of three sequential, randomized, controlled studies of repeated treatments with botulinum toxin type A for migraine prophylaxis. The Journal of Pain : Official Journal of the American Pain Society, 7(10), 688-96.
Elkind AH, et al. A Series of Three Sequential, Randomized, Controlled Studies of Repeated Treatments With Botulinum Toxin Type a for Migraine Prophylaxis. J Pain. 2006;7(10):688-96. PubMed PMID: 17018329.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A series of three sequential, randomized, controlled studies of repeated treatments with botulinum toxin type A for migraine prophylaxis. AU - Elkind,Arthur H, AU - O'Carroll,Philip, AU - Blumenfeld,Andrew, AU - DeGryse,Ronald, AU - Dimitrova,Rozalina, AU - ,, PY - 2005/09/19/received PY - 2006/03/15/revised PY - 2006/03/15/accepted PY - 2006/10/5/pubmed PY - 2006/12/14/medline PY - 2006/10/5/entrez SP - 688 EP - 96 JF - The journal of pain : official journal of the American Pain Society JO - J Pain VL - 7 IS - 10 N2 - UNLABELLED: We examined the effects of multiple treatments with low doses of botulinum toxin type A (BoNTA; BOTOX(R), Allergan Inc., Irvine, CA) versus placebo for prophylaxis of episodic migraine. This was a series of 3 sequential, randomized, controlled studies of 418 patients with a history of 4 to 8 moderate to severe migraines per month. In study I, patients were randomized to treatment with placebo or BoNTA (7.5 U, 25 U, or 50 U) in predetermined fixed injection sites on the front and sides of the head only. In study II, patients continued to receive, or were randomized to, 2 consecutive treatments with 25 U or 50 U. In study III, patients were randomized to placebo or continuation of 25 U or 50 U. Injection cycles were each 4 months long. BoNTA and placebo produced comparable decreases from baseline in the frequency of migraines at each time point examined (P >or= .201). No consistent, statistically significant differences were observed for any efficacy variable. Adverse events were similar among the groups within each study. In these exploratory studies of episodic migraine patients, repeated injections of low doses of BoNTA into fixed frontal, temporal, and glabellar sites were not more effective than placebo. BoNTA was safe and well tolerated. PERSPECTIVE: Beneficial effects of BoNTA in the treatment of migraine have been reported, but positive results are not universal, possibly because the optimal patient population and regimen are not yet definitively established. This study explores the effects of multiple injections of low BoNTA doses into fixed sites for episodic migraine. SN - 1526-5900 UR - https://www.unboundmedicine.com/medline/citation/17018329/A_series_of_three_sequential_randomized_controlled_studies_of_repeated_treatments_with_botulinum_toxin_type_A_for_migraine_prophylaxis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1526-5900(06)00628-6 DB - PRIME DP - Unbound Medicine ER -