Official Title: “A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Elimination of Migraine-Associated Nausea in Migraine Patients Treated With Rizatriptan Orally Disintegrating Tablet (ODT)”

Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.

Study Type: Interventional

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

Study Primary Completion Date: October 2006

Intervention(s) in this Clinical Trial

• Drug: Comparator: Rizatriptan
  • One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.
• Drug: Comparator: Placebo
  • One dose matching placebo to Rizatriptan to treat one migraine attack.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Rizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate
• Placebo Comparator: 2
  • matching placebo

Primary Measures

• Percentage of patients with elimination of nausea at 2 hours postdose
  • Time Frame: 2 hours post-dose
    Safety Issue?: No

Secondary Measures

• Percentage of patients with pain relief at 2 hours postdose
  • Time Frame: 2 hours post-dose
    Safety Issue?: No

Inclusion Criteria:

• 6-month history of migraine, moderate to severe migraine attacks with nausea, 1-6 migraine attacks per month

Exclusion Criteria:

• Heart disease, 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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00250458

Study ID Number: 2005_081

ClinicalTrials.gov Identifier: NCT00250458

Health Authority: United States: Food and Drug Administration

MedWatch - FDA maintained medical product safety Information

PhRMA Clinical Study Results Database - web-based repository for clinical study results

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