Study to Test Rizatriptan in the Early Treatment of Acute Migraine

Official Title: “A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine”

The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.

Intervention(s) in this Clinical Trial

• Drug: Comparator: rizatriptan benzoate
  • Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
• Drug: Comparator: Placebo
  • Matching placebo; one dose, treatment of a single migraine attack

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Active Drug
• Placebo Comparator: 2
  • Matching Pbo Comparator

Primary Measures

• Number of Participants Who Are Pain Free at 2 Hours Post-Dose
  • Time Frame: 2 hours post-dose
    Safety Issue?: No

Secondary Measures

• Number of Participants With 24-Hour Sustained Pain Freedom
  • Time Frame: 24 hours post-dose
    Safety Issue?: No
• Number of Participants With no Rescue Use up to 24 Hours Post-Dose
  • Time Frame: 24 hours post-dose
    Safety Issue?: No
• Number of Participants With Absence of Photophobia at 2 Hours Post-dose
  • Time Frame: 2 hours post-dose
    Safety Issue?: No
• Number of Participants With Absence of Phonophobia at 2 Hours Post-dose
  • Time Frame: 2 hours post-dose
    Safety Issue?: No
• Number of Participants With Absence of Nausea at 2 Hours Post-dose
  • Time Frame: 2 hours post-dose
    Safety Issue?: No
• Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose
  • Time Frame: 2 hours post-dose
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00516737

Study ID Number: 2007_547

ClinicalTrials.gov Identifier: NCT00516737

Health Authority: United States: Food and Drug Administration

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site