PREEMPTIVE ORAL TREATMENT WITH SUMATRIPTAN DURING A CLUSTER PERIOD

This multinational, multicenter, randomized, double-blind, placebo-con trolled study in 169 patients investigated the effect of a 7-day perio d of preemptive treatment with oral sumatriptan (100 mg tid) on the fr equency and severity of cluster headache attacks occurring during an e stablished cluster headache period. Safety and tolerability were also assessed. Cluster headache patients who were not taking prophylactic m edication and had experienced seven or more attacks in the preceding o bservation week, treated a cluster headache attack at home with subcut aneous sumatriptan 6 mg using an autoinjector device. Patients were th en randomized to take sumatriptan 100 mg or placebo at 8-hourly interv als for a 7-day period. Cluster headaches occurring during this period could be treated 5 minutes after onset with rescue medication (100% o xygen or simple analgesics). Diary cards were used to record details o f the cluster headache pattern during the observation and study treatm ent weeks. Preemptive oral treatment with sumatriptan 100 mg tid for 7 days did not produce a significant reduction in the number or severit y of cluster headache attacks occurring during an established cluster headache period. Oral treatment with sumatriptan 100 mg tid over a 7-d ay period was not associated with an increased or altered adverse even t profile from that previously reported.