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Clinical Profile of Botulinum Toxin A in Patients with Chronic
Headaches and Cervical Dystonia: A Prospective, Open-Label,
Longitudinal Study Conducted in a Naturalistic Clinical
Practice Setting
Dowson AJ, Kilminster SG, Salt R.
Posted: December 2008  
Drugs R D.   2008;9:147-158

Background and objectives:   Some evidence for the efficacy of botulinum toxin A as a preventive treatment for chronic primary headaches has been reported in randomized, controlled clinical studies. This study investigated the clinical profile of botulinum toxin A in a naturalistic clinical practice setting in a population of patients with cervical dystonia associated with chronic headache and a history of migraine.

Methods:   This was a prospective, open-label, longitudinal study. Following a prospective run-in period, eligible patients were given three sets of botulinum toxin A injections at 8- to 12-week intervals over a 16- to 24-week period and were monitored for 3 months after the final injections. Efficacy was assessed in terms of headache-related disability, pain and emotional function, qualify of life and patient-assessed headache frequency and severity, and medication use and its effectiveness. Safety was assessed as adverse events.

Results:   Twenty-four patients took part in the study and 17 completed the study. There were significant improvements in headache-related disability, pain and emotional function, headache frequency and medication use following treatment with botulinum toxin A. An efficacy response occurred within 8 weeks of treatment initiation and was maintained throughout the study duration. Botulinum toxin A was generally well tolerated.

Conclusions:   This study demonstrated that botulinum toxin A is an effective and well-tolerated preventive treatment for chronic headache in patients with cervical dystonia and a history of migraine. These results warrant further investigation in a large, randomized, controlled study.