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 a marketed drug in the early treatment of an acute migraine attack.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: rizatriptan benzoate
  • rizatriptan benzoate 10 mg ODT tablet, within 2 hrs of migraine onset.
• Drug: Comparator: placebo (unspecified)
  • rizatriptan benzoate Pbo 10 mg ODT tablet, within 2 hrs of migraine onset.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Arm 1: Drug
• Placebo Comparator: 2
  • Arm 2: Pbo Comparator

Primary Measures

• Percentage of patients who are pain free
  • Time Frame: 2 hours postdose
    Safety Issue?: No
• Tolerability as measured by subjective adverse experience reporting
  • Time Frame: 24hr post dose
    Safety Issue?: No

Secondary Measures

• Percentage of patients with 24hr sustained pain freedom, associated symptoms, and use of rescue medication
  • Time Frame: 24hr 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 Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on August 29, 2008

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