Medical College of Wisconsin
CTSICores SearchResearch InformaticsREDCap

Botulinum Toxin Type A in the treatment of chronic migraine without medication overuse. Headache 2008 Feb;48(2):201-9 PMID: 18042229

Pubmed ID



INTRODUCTION: Chronic migraine is a recent diagnostic term that has undergone evolution from its original description. Clinically it has been believed that medication overuse contributed to its development and would block attempts at prevention. Previous studies with Botulinum Toxin Type A have demonstrated that it is effective even in patients with medication overuse. This study undertakes to examine the effects of Botulinum Toxin Type A in the absence of medication overuse in patients with chronic migraine.

STUDY DESIGN: Double-blind placebo-controlled randomized trial of Botulinum Toxin Type A 100 units administered in a fixed dose and site paradigm.

PATIENTS: In total, 86 patients were enrolled. A total of 60 patients were randomized and 41 patients were treated with the study medication or placebo. Five patients failed to complete the study, which lasted 4 months after the study medication was injected.

RESULTS: Botulinum Toxin Type A was statistically superior to placebo for the primary endpoint of reduction in migraine headache episodes. Six patients on Botulinum Toxin Type A compared with 3 patients on Placebo had at least a 50% reduction in their migraine episodes. Active treatment was superior to placebo for the secondary endpoints of total headache days, headache index, and quality of life measures. It showed numerical superiority to placebo for acute medication use and Migraine Disability Assessment Scores. Adverse events were rare and similar in both treatment groups.

CONCLUSIONS: The use of Botulinum Toxin Type A may be an effective treatment for chronic migraine when the patient does not have concomitant medication overuse. It was well tolerated in this trial.

Author List

Freitag FG, Diamond S, Diamond M, Urban G


Frederick G. Freitag DO Associate Professor in the Neurology department at Medical College of Wisconsin


2-s2.0-38849192498   67 Citations

MESH terms used to index this publication - Major topics in bold

Botulinum Toxins, Type A
Chronic Disease
Double-Blind Method
Drug Evaluation
Middle Aged
Migraine Disorders
Neuromuscular Agents
Outcome Assessment (Health Care)
jenkins-FCD Prod-331 a335b1a6d1e9c32173c9534e6f6ff51494143916