Phase 3
Completed N=1,068
Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012)
Source: ClinicalTrials.gov NCT00443209 ↗Enrolled (actual)
1,068
Serious AEs
1.9%
Results posted
Aug 2014
Primary outcomePrimary: Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE) — 5.0; 11.2 Percentage of Participants — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE) |
5.0; 11.2 | <0.001 sig |
| PRIMARY Percentage of Participants With At Least One Clinical AE |
58.7; 63.9 | — |
| PRIMARY Percentage of Participants With At Least One Laboratory AE |
1.9; 1.6 | — |
| PRIMARY Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change |
0.2; 0.3; 1.4; 1.3; 0.3; 0.6 | — |
| SECONDARY Percentage of Participant Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose |
38.9; 47.5 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00443209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.