Phase 3
Completed N=165
Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)
Migraine Disorders · Heart Failure · Cerebrovascular Accident · TIA (Transient Ischemic Attack)
Source: ClinicalTrials.gov NCT00662818 ↗
Enrolled (actual)
165
Serious AEs
0.5%
Results posted
Sep 2014
Primary outcomePrimary: Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1) — 25.0; 18.9 Percentage of participants — p=0.329
Summary
The purpose of this study is to evaluate the safety and efficacy of telcagepant in the treatment of acute migraine in participants with stable vascular disease. Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. The primary hypothesis of this study is that telcagepant 300 mg is superior to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1) |
25.0; 18.9 | 0.329 |
| PRIMARY Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose |
21; 14 | — |
| PRIMARY Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose |
0; 0 | — |
| SECONDARY Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1) |
63.5; 56.6 | 0.420 |
| SECONDARY Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose |
0; 0 | — |
| SECONDARY Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1) |
65.4; 58.5 | 0.648 |
| SECONDARY Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1) |
53.8; 58.5 | 0.647 |
| SECONDARY Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1) |
80.8; 69.8 | 0.201 |
| SECONDARY Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose |
19.2; 15.4 | 0.579 |
Eligibility Criteria
Inclusion Criteria
- Stable coronary artery disease for 3 months or more
- 18 years of age or older with a history of migraine with or without aura
- Must use acceptable contraception throughout the study
Exclusion Criteria
- Pregnant, breast-feeding, or planning to become pregnant during this study
- 50 years of age or older when migraines began
- Other pain syndromes that might interfere with study assessments, uncontrolled psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
- History of gastric, or small intestinal surgery, or has a disease that causes malabsorption
Data sourced from ClinicalTrials.gov (NCT00662818). 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.