Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Extension Protocols MK-0462-022, MK-0462-025, MK-0462-029)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine Disorders
Intervention: Rizatriptan 5 mg (Drug); Rizatriptan 10 mg (Drug); Standard Care (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Protocols 022, 025, 029)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test DrugNumber of Participants With Serious Clinical Adverse Experiences Number of Participants With Drug-related Clinical Adverse Experiences Number of Participants Who Discontinued Due to Clinical Adverse Experiences Number of Participants With Drug-related Lab Adverse Experiences
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Participant took part in study MK-0462-022, MK-0462-025, or MK-0462-029
- History of migraine headache
Locations and Contacts
Additional Information
Starting date: March 1995
Last updated: February 13, 2015
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