Imitrex Clinical Trials and Studies
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Imitrex Clinical Trials and Studies
The efficacy of Imitrex (sumatriptan succinate) tablets in the acute treatment of migraine headaches was demonstrated in three, randomized, double-blind, placebo-controlled studies. Patients enrolled in these three studies were predominately female (87%) and Caucasian (97%), with a mean age of 40 (range of 18 to 65). Patients were instructed to treat a moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed up to 4 hours after dosing. Associated symptoms such as nausea, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24 hours postdose. A second dose of Imitrex (sumatriptan succinate) tablets or other medication was allowed 4 to 24 hours after the initial treatment for recurrent headache. Acetaminophen was offered to patients in Studies 2 and 3 beginning at 2 hours after initial treatment if the migraine pain had not improved or worsened. Additional medications were allowed 4 to 24 hours after the initial treatment for recurrent headache or as rescue in all three studies. The frequency and time to use of these additional treatments were also determined. In all studies, doses of 25, 50, and 100 mg were compared to placebo in the treatment of migraine attacks. In one Imitrex study, doses of 25, 50, and 100 mg were also compared to each other.
In all three trials, the percentage of patients achieving headache response 2 and 4 hours after treatment was significantly greater among patients receiving Imitrex (sumatriptan succinate) tablets at all doses compared to those who received placebo. In one of the three studies, there was a statistically significant greater percentage of patients with headache response at 2 and 4 hours in the 50- or 100-mg group when compared to the 25-mg dose groups. There were no statistically significant differences between the 50- and 100-mg Imitrex dose groups in any study.
For patients with migraine-associated nausea, photophobia, and/or phonophobia at baseline, there was a lower incidence of these symptoms at 2 hours (Study 1) and at 4 hours (Studies 1, 2, and 3) following administration of Imitrex (sumatriptan succinate) tablets compared to placebo.
As early as 2 hours in Studies 2 and 3 or 4 hours in Study 1, through 24 hours following the initial dose of Imitrex treatment, patients were allowed to use additional treatment for pain relief in the form of a second dose of Imitrex treatment or other medication.
There is evidence that doses above 50 mg do not provide a greater effect than 50 mg. There was no evidence to suggest that treatment with Imitrex (sumatriptan succinate) was associated with an increase in the severity of recurrent headaches. The efficacy of Imitrex (sumatriptan succinate) tablets was unaffected by presence of aura; duration of headache prior to treatment; gender, age, or weight of the patient; relationship to menses; or concomitant use of common migraine prophylactic drugs (e.g., beta-blockers, calcium channel blockers, tricyclic antidepressants). There were insufficient data to assess the impact of race on efficacy.
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