A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. This study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of migraine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,268
single dose administration of 5mg rizatriptan (by Mouth) p.o.
single dose administration of 10 mg rizatriptan p.o.
single dose administration of sumatriptan 100 p.o.
Pain Relief at 2 Hours After Dose
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment
Time frame: 2 hours after dose
Time to Relief Within 2 Hours After Dose
Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose
Time frame: within 2 hours after dose
Pain Free at 2 Hours After Dose
Patients pain free (defined as a reduction of headache severity to grade 0 \[no pain\]) at 2 hours after treatment. Each patient rated headache severity on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
Time frame: 2 hours after dose
Functional Status at 2 Hours After Dose
Patients with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each patient rated functional disability on a 4-grade scale (0 = no functional disability; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 = unable to carry out daily activities, requires bed rest).
Time frame: 2 hours after dose
Nausea at 2 Hours After Dose
Patients who recorded the presence or absence of nausea 2 hours after dose
Time frame: 2 hours after dose
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placebo to rizatriptan