A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
933
single dose 5 mg rizatriptan p.o.
single dose 50 mg sumatriptan p.o.
Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally
Pain Relief at 2 Hours After Treatment
Participants 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 treatment
Time to Relief Within 2 Hours After Treatment
Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).
Time frame: within 2 hours after treatment
Pain Free at 2 Hours After Treatment
Participants pain free (defined as a reduction of headache severity to grade 0 \[no pain\]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
Time frame: 2 hours after treatment
Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities
Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest).
Time frame: 2 hours after treatment
Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment
Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.
Time frame: 2 hours after treatment
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Participants Who Used Escape Medication 2 Hours After the Treatment Dose
Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.
Time frame: 2 hours after treatment
Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])
Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence
Time frame: 24 hours