In the first three months of a 24-month open study to assess the safet
y and efficacy of subcutaneous sumatriptan 6 mg in the long-term acute
treatment of cluster headache, 138 patients treated a maximum of two
attacks daily each with a single 6 mg injection. A total of 6353 attac
ks were treated. Adverse events, reported in 28% of sumatriptan-treate
d attacks, were qualitatively similar to those seen in migraine long-t
erm trials. Their incidence did not increase with frequent use of suma
triptan. There were no clinically significant treatment effects on vit
al signs, ECG recordings or laboratory parameters. Headache relief (a
reduction from very severe, severe or moderate pain to mild or no pain
) at 15 min was obtained for a median of 96% of attacks treated. There
was no indication of tachyphylaxis, decrease in the speed of response
, or increased frequency of attacks with long-term treatment. This stu
dy demonstrated that, in long-term use, subcutaneous sumatriptan 6 mg
is a well-tolerated and effective acute treatment for duster headache.