Phase 3
Completed N=1,959
Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Extension Protocols MK-0462-022, MK-0462-025, MK-0462-029)
Migraine Disorders
Source: ClinicalTrials.gov NCT01286207 ↗
Enrolled (actual)
1,959
Serious AEs
2.1%
Results posted
Jun 2011
Primary outcomePrimary: Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug — 80; 89.5; 69.6 percent of headaches
Summary
This record describes pooled data for three extension studies: MK-0462-022 (NCT00897949); MK-0462-025 (NCT00899379); and MK-0462-029 (NCT00897104). These studies examined the long-term safety and efficacy of rizatriptan used for the treatment of acute migraine and migraine recurrence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug |
80; 89.5; 69.6 | — |
| PRIMARY Number of Participants With Serious Clinical Adverse Experiences |
13; 17; 10; 698; 817; 324 | — |
| PRIMARY Number of Participants With Drug-related Clinical Adverse Experiences |
288; 456; 139; 423; 378; 195 | — |
| PRIMARY Number of Participants Who Discontinued Due to Clinical Adverse Experiences |
26; 37; 7; 685; 797; 327 | — |
| PRIMARY Number of Participants With Drug-related Lab Adverse Experiences |
15; 23; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Participant took part in study MK-0462-022, MK-0462-025, or MK-0462-029
- History of migraine headache
Data sourced from ClinicalTrials.gov (NCT01286207). 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.