Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012)

• Status: Completed
• Trial end date: 2009-01-22
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the safety and tolerability of telcagepant (MK-0974) in the long-term treatment of acute migraine in adult participants. The primary hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of acute migraine in adult participants.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Rizatriptan

Criteria

Inclusion Criteria:

• At least 1 year history of migraine (with or without aura)

• Females of child bearing potential must use acceptable contraception throughout trial

• In general good health based on screening assessment

Exclusion Criteria:

• Pregnant/breast-feeding (or is a female expecting to conceive during study period)

• 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 human immunodeficiency virus (HIV) disease

• Major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)

• History of gastric, or small intestinal surgery, or has a disease that causes malabsorption

• History of cancer within the last 5 years