Phase 3
N=207
Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT00516737 ↗Enrolled (actual)
207
Serious AEs
0.0%
Results posted
Apr 2009
Primary outcome: Primary: Number of Participants Who Are Pain Free at 2 Hours Post-Dose — 61; 27 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Comparator: rizatriptan benzoate (Drug); Comparator: Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Are Pain Free at 2 Hours Post-Dose |
61; 27 | — |
| SECONDARY Number of Participants With 24-Hour Sustained Pain Freedom |
48; 17 | — |
| SECONDARY Number of Participants With no Rescue Use up to 24 Hours Post-Dose |
61; 32 | — |
| SECONDARY Number of Participants With Absence of Photophobia at 2 Hours Post-dose |
69; 43 | — |
| SECONDARY Number of Participants With Absence of Phonophobia at 2 Hours Post-dose |
72; 55 | — |
| SECONDARY Number of Participants With Absence of Nausea at 2 Hours Post-dose |
82; 73 | — |
| SECONDARY Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose |
66; 42 | — |
Summary
The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.
Eligibility Criteria
Inclusion Criteria
- Greater than one year history of migraine
- Attacks typically mild when they begin and progress to moderate or severe
- Experience 1-4 migraine attacks per month
Exclusion Criteria
- More than 15 headache days per month
- Heart disease
- Uncontrolled high blood pressure
Data sourced from ClinicalTrials.gov (NCT00516737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.