Status:
COMPLETED
Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 stud...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 21 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2009
Estimated Enrollment :
1068 Patients enrolled
Trial Details
Trial ID
NCT00443209
Start Date
February 21 2007
End Date
January 22 2009
Last Update
October 17 2018
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