Headache Drugs Logo
Home | About Dr. Robbins | Archived Articles | Headache Books | Topic Index  

Back to List



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

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.