The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
207
Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Matching placebo; one dose, treatment of a single migraine attack
Number of Participants Who Are Pain Free at 2 Hours Post-Dose
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.
Time frame: 2 hours post-dose
Number of Participants With 24-Hour Sustained Pain Freedom
24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.
Time frame: 24 hours post-dose
Number of Participants With no Rescue Use up to 24 Hours Post-Dose
Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.
Time frame: 24 hours post-dose
Number of Participants With Absence of Photophobia at 2 Hours Post-dose
Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.
Time frame: 2 hours post-dose
Number of Participants With Absence of Phonophobia at 2 Hours Post-dose
Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.
Time frame: 2 hours post-dose
Number of Participants With Absence of Nausea at 2 Hours Post-dose
Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.
Time frame: 2 hours post-dose
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Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose
Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose.
Time frame: 2 hours post-dose