INTRODUCTION OF A NOVEL SELF-INJECTOR FOR SUMATRIPTAN - A CONTROLLED CLINICAL-TRIAL IN GENERAL-PRACTICE

A novel self-injector for the administration of subcutaneous sumatript an in the treatment of migraine attacks was tested in 138 patients rec ruited by family physicians in Denmark; 108 patients completed the ini tial double-blind, crossover part of the study. Sumatriptan 6 mg s.c. was significantly better than placebo at 30, 60, 90 and 120 min after injection in relieving moderate or severe headache to mild or none as well as relieving any headache to none. At 60 min after injection, the treatment response rate was 61% for sumatriptan and 6% for placebo. D uring the following open-phase trial of four attacks treated with suma triptan, treatment response rates were 68-74%. During the total of 538 attacks treated, 12 attempts at using the self-injector failed. In th e double-blind and open phases, 81% and 90% of patients respectively f ound the device easy or very easy to use. Adverse effects were benign and short-lasting, but led seven patients to discontinue the study. In conclusion, subcutaneous sumatriptan administered with a novel self-i njector is an effective treatment for migraine compared to placebo in patients treated by their family physician.