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Headache Drugs: Zanaflex

An Open-Label Dose-Titration Study of the Efficacy and Tolerability of Tizanidine Tablets in the Prophylaxis of Chronic Daily Headache (Posted June 2001)

Low Dose Tizanidine Combined With Long-Acting NSAIDs for Detoxification From Analgesic Rebound Headache (Posted Jan 2001)

Tizanidine in the Preventative Treatment of Chronic Tension Type Headache (Posted June 2000)

Tizanidine in the Preventative Treatment of Chronic Tension Type Headache

To assess the efficacy of tizanidine in the open label preventative treatment of chronic tension type headache (CTTH).

This was an open label study of tizanidine 2-32 mg. per day for 3 months. Dose adjustments being made on the basis of efficacy and tolerability. Outcome assessment was the change in the number of headache days per 28-day period. Successful outcome was a 50% or greater reduction in headache days. Patients were allowed to remain on concurrent preventative treatment if the dose had been stable for 1 month. Acute therapies were permitted, provided that the patient did not also have analgesic abuse headache by IHS criteria.

61 patients had CTTH with a pericranial muscle disorder (CTTH-PM), 18 patients had CTTH without involvement of the pericranial muscles (CTTH-NOPM). 30 or 43 patients with CTTH-PM improved. 3 of 18 patients with CTTH-NOPM also improved (Chi-square p<0.001). The mean dose of patients with CTTH-PM that improved was 8.4 mg. per day compared to 6 mg. per day for non responders. For patients with CTTH-NOPM the mean dose for responders was 8 mg. per day and 7.6 mg. per day for non responders (Mann-Whitney rank sum p=1). 4 patients discontinued treatment in the first month secondary to adverse effects (AE). 2 patients whose data was included for efficacy analysis stopped between 4 and 12 weeks due to AE. The only AE reported by patients was tiredness.

Tizanidine may be an effective agent in the preventative treatment of CTTH especially if there is involvement of the pericranial muscles.