^* p<0.05 versus placebo.
^† Includes patients that may have received an additional placebo injection 1 hour after the initial injection.
^† Includes patients that may have received an additional 6 mg of IMITREX Injection 1 hour after the initial injection.
^§ A successful outcome in terms of clinical disability was defined prospectively as ability to work mildly impaired or ability to work and function normally.

IMITREX Injection also relieved photophobia, phonophobia (sound sensitivity), nausea, and vomiting associated with migraine attacks. Similar efficacy was seen when patients self-administered IMITREX Injection using an autoinjector.

The efficacy of IMITREX Injection is unaffected by whether or not migraine is associated with aura, duration of attack, gender or age of the patient, or concomitant use of common migraine prophylactic drugs (e.g., beta-blockers).

Cluster Headache: The efficacy of IMITREX Injection in the acute treatment of cluster headache was demonstrated in 2 randomized, double-blind, placebo-controlled, 2-period crossover trials. Patients age 21 to 65 were enrolled and were instructed to treat a moderate to very severe headache within 10 minutes of onset. Headache relief was defined as a reduction in headache severity to mild or no pain. In both trials, the proportion of individuals gaining relief at 10 or 15 minutes was significantly greater among patients receiving 6 mg of IMITREX Injection compared to those who received placebo (see Table 3). One study evaluated a 12-mg dose; there was no statistically significant difference in outcome between patients randomized to the 6- and 12-mg doses.

^*p<0.05.
(n = Number of headaches treated.)

The Kaplan-Meier (product limit) Survivorship Plot (Figure 1) provides an estimate of the cumulative probability of a patient with a cluster headache obtaining relief after being treated with either sumatriptan or placebo.

^*Patients taking rescue medication were censored at 15 minutes.

The plot was constructed with data from patients who either experienced relief or did not require (request) rescue medication within a period of 2 hours following treatment. As a consequence, the data in the plot are derived from only a subset of the 258 headaches treated (rescue medication was required in 52 of the 127 placebo-treated headaches and 18 of the 131 sumatriptan-treated headaches).

Other data suggest that sumatriptan treatment is not associated with an increase in early recurrence of headache, and that treatment with sumatriptan has little effect on the incidence of latter-occurring headaches (i.e., those occurring after 2, but before 18 or 24 hours).

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