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An Open-Label Dose-Titration Study
of the Efficacy and Tolerability of
Tizanidine Tablets in the Prophylaxis of
Chronic Daily Headache
Joel Saper, etal.
Posted June 2001
Headache, April 2001
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Objective: To asess effectiveness and safety of tizanidine
hydrochloride tablets for the prophylaxis of chronic daily
headache.
Design: Thirty-nine patients with more than 15 headache days
per month (33 with migraine, 5 migrainous, 1 chronic tension-type) completed
a 4-week baseline, with 31 completing a planned 12 weeks of treatment with
tizanidine. Dosing was titrated from 2 mg at bedtime to a median daily
dose of 14 mg by treatment week 4.
Results: The overall headache index through week 12 declined
significantly. Overall headache frequency declined, frequency of severe
headaches declined, average headache intensity declined, and duration was
reduced. Mild-to-moderate adverse events reported by more
than 10% of the patients included somnolence, asthenia, and dry mouth. Only 3 patients discontinued treatment due to adverse events. One patient
had elevated liver enzymes that returned to normal after the drug was
discontinued.
Conclusions: The results provide preliminary support for the
efficacy, safety, and tolerability of tizanidine in the prophylaxis of chronic
daily headache.
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