MK0974 Long Term Safety Study

Official Title: “Long-Term Intermittent Treatment of Acute Migraine With MK0974”

The purpose of this study is to investigate the safety and tolerability of MK0974 in the long-term treatment of acute migraine.

Intervention(s) in this Clinical Trial

• Drug: Comparator: MK0974
  • MK0974 280 mg tablet at onset of migraine. Total treatment will be up to 18 months.
• Drug: Comparator: rizatriptan
  • Rizatriptan 10 mg tablet at onset of migraine. Total treatment will be up to 18 months.
• Drug: Comparator: Placebo to MK0974
  • Placebo to MK0974 tablet at onset of migraine. Total treatment will be up to 18 months.
• Drug: Comparator: Placebo to rizatriptan
  • Placebo to rizatriptan at onset of migraine. Total treatment will be up to 18 months.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • MK0974
• Active Comparator: 2
  • Rizatriptan

Primary Measures

• Adverse experiences, laboratory values, ECGs, and vital signs during the study period.
  • Time Frame: During the study
    Safety Issue?: No

Secondary Measures

• Pain freedom at 2 hours postdose.
  • Time Frame: 2 hours post-dose
    Safety Issue?: No

Inclusion Criteria:

• Patient has at least 1 year history of migraine (with or without aura)
• Females of child bearing potential must use acceptable contraception throughout trial
• Patient is in general good health based on screening assessment

Exclusion Criteria:

• Patient is pregnant/breast-feeding (or is a female expecting to conceive during study period)
• Patient has history or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or HIV disease
• Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
• Patient has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
• Patient has a history of cancer within the last 5 years

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 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00443209

Study ID Number: 2006_524

ClinicalTrials.gov Identifier: NCT00443209

Health Authority: United States: Food and Drug Administration