Phase 3
Completed N=473
Treatment of Multiple Attacks of Acute Migraine (0462-025)
Migraine Headache
Source: ClinicalTrials.gov NCT00899379 ↗
Enrolled (actual)
473
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcomePrimary: Pain Relief at 2 Hours During the First Migraine Attack Period — 246; 30; 74; 52 participants
Summary
A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine compared to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Relief at 2 Hours During the First Migraine Attack Period |
246; 30; 74; 52 | — |
| SECONDARY Pain Relief at 2 Hours During the Second Migraine Attack Period |
228; 27; 63; 46 | — |
| SECONDARY Pain Relief at 2 Hours During the Third Migraine Attack Period |
207; 21; 52; 54 | — |
| SECONDARY Pain Relief at 2 Hours During the Fourth Migraine Attack Period |
190; 31; 65; 26 | — |
Eligibility Criteria
Inclusion Criteria
- Patient had at least a 6-month history of migraine, with or without aura
- Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions.
- Patient was judged to be in good health, apart from migraine
Exclusion Criteria
- Patient was pregnant or a nursing mother.
- Patient had abused drugs or alcohol within 12 months prior to entering the study
- Patient had a history of cardiovascular disease
- Patient had clinically significant ECG abnormality
- Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
- Patient received treatment with an investigational device or compound within 30 days of the study start
- Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
- Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
- Patient had prior exposure to rizatriptan
Data sourced from ClinicalTrials.gov (NCT00899379). 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. Informational only — not medical advice.