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Botulinum Toxin Type A as Migraine Preventive Treatment
in Patients Previously Failing Oral Prophylactic Treatment
Due to Compliance Issues
Roger Cady, MD; Curtis Schreiber, MD
Posted: July 2008  
Headache   2008;48:900-913

Objective:   To examine the efficacy and safety of and satisfaction with botulinum toxin type A (BoNTA: BOTOX®:Allergan, Inc., Irvine, CA) for prophylactic treatment of migraine headache in patients previously failing prophylaxis because of issues pertaining to compliance.

Background:   Numerous factors (adverse effects, tolerability, cost, frequency of dosage, hesitancy to take daily medication, failure to complete treatment) negatively influence compliance with the preventive pharmacology for migraine prophylaxis. BoNTA may offer benefit in improving compliance because of its long duration of action, injectable route of administration, and its tolerability (adverse event) profile.

Methods:   This was a randomized, double-blind, single-center, placebo-controlled study (months 1 to 3) of BoNTA with a cross-over to open-label BoNTA treatment (months 4 to 6). Criteria for enrollment included patients with disabling headache previously failing prophylaxis because of compliance, tolerability, or adherence issues. After baseline evaluation, subjects were randomized 2:1 to a single set of BoNTA or placebo injections. After month 3, only placebo-treated subjects were eligible to receive BoNTA in the open-label continuation study. Treatment outcomes were evaluated by headache episodes and days and maximum headache severity. Headache impact and treatment satisfaction were also assessed.

Conclusions:   BoNTA-treated subjects showed improvements from baseline in measures of headache frequency, and improvements from baseline and in comparison with placebo treatment in headache impact and treatment satisfaction at multiple time points in this study. However, BoNTA-treated subjects did not differ from placebo-treated subjects in measures of headache frequency and severity. BoNTA may be a useful treatment option for headache patients demonstrating poor compliance, adherence, or adverse event profile with oral prophylactic regimens.