Official Title: “A Double-Blind, Randomized, Placebo-Controlled, 3-Period, Single Dose Crossover Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK0974 in Migraine Patients”

Study to understand the effects of blood pressure in patients with migraine.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety Study

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: MK0974
  • MK0974; 600 mg (2 x300 mg capsule) Duration of Treatment: 2 Days
• Drug: sumatriptan
  • single, oral dose of 100 mg sumatriptan Duration of Treatment: 2 Days
• Drug: placebo (unspecified)
  • Pbo sumatriptan Duration of Treatment: 2 Days
• Drug: placebo (unspecified)
  • Pbo MK0974 Duration of Treatment: 2 Days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • drug-drug
• Active Comparator: B
  • drug placebo
• Experimental: C
  • placebo drug
• Placebo Comparator: D
  • placebo, placebo

Primary Measures

• Assessment of the blood pressure effect of a single dose of comparator alone versus comparator with investigational product in migraineurs.
  • Time Frame: Up to 6 hours postdose.
    Safety Issue?: No

Secondary Measures

• Assessment of the safety and tolerability of a single dose of comparator alone versus comparator with investigational product in migraineurs. Assessment of the blood pressure effect of a single dose of investigational product vs. placebo in migraineurs.
  • Time Frame: Up to 6 hours postdose.
    Safety Issue?: No

Inclusion Criteria:

• Patient has history of migraine for longer than 6 months.
• Patient is free from migraine 24 hours before each dosing.
• Patient is judged to be in good health.
• Nonsmoker

Exclusion Criteria:

• Under age of legal consent.
• Legally or mentally incapacitated or has significant emotional problems.
• Patient is taking any medications from about 2 weeks before the first dose of study medication.
• Patient has had surgery or donated blood or participated in another investigation study within 4 weeks prior to screening
• Patient is currently a regular user of any illicit drugs or has a history of drug/alcohol abuse within about 2 years
• Patient consumes more than 6 caffeinated beverages per day

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

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/NCT00701389

Study ID Number: 2008_500

ClinicalTrials.gov Identifier: NCT00701389

Health Authority: United States: Food and Drug Administration