Phase 3
N=1,380
Study of Telcagepant (MK-0974) in Participants With Moderate to Severe Acute Migraine With or Without Aura (MK-0974-011)
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT00442936 ↗Enrolled (actual)
1,380
Serious AEs
0.1%
Results posted
Aug 2014
Primary outcome: Primary: Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose — 56; 89; 101; 29 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Telcagepant potassium 150 mg (Drug); Telcagepant potassium 300 mg (Drug); Zolmitriptan 5 mg (Drug); Placebo to telcagepant 150 mg (Drug); Placebo to tecagepant 300 mg (Drug); Placebo to zolmitriptan 5 mg (Drug); Rescue medication (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose |
56; 89; 101; 29 | <0.001 sig |
| PRIMARY Number of Participants With Pain Relief (PR) at 2 Hours Post-Dose |
157; 183; 185; 88 | <0.001 sig |
| PRIMARY Number of Participants With Absence of Photophobia at 2 Hours Post-Dose |
143; 169; 163; 92 | <0.001 sig |
| PRIMARY Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose |
170; 193; 180; 120 | <0.001 sig |
| PRIMARY Number of Participants With Absence of Nausea at 2 Hours Post-Dose |
212; 218; 232; 179 | <0.001 sig |
| PRIMARY Number of Participants Who Experience At Least One Adverse Event (AE) |
105; 131; 175; 112 | — |
| PRIMARY Number of Participants Who Discontinue Study Drug Due to an AE |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Sustained Pain Freedom (SPF) From 2 to 24 Hours Post-Dose |
34; 66; 59; 14 | 0.002 sig |
| SECONDARY Number of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose |
43; 76; 87; 27 | 0.026 sig |
| SECONDARY Number of Participants With Total Migraine Freedom (TMF) at 2 to 24 Hours Post-Dose |
26; 57; 51; 13 | 0.021 sig |
Summary
The purpose of this study is to investigate the efficacy and safety of telcagepant (MK-0974) compared to an approved medication for acute migraine. This study was conducted as a "triple-dummy" design; for each dose of study drug, participants each received 3 forms of study drug (2 capsules of active and/or placebo and 1 tablet of active and/or placebo) and were instructed to take one of each form of study drug at dosing time.
The primary hypotheses of this study are that telcagepant is superior to placebo in Pain Freedom at 2 Hours Post-Dose, Pain Relief at 2 Hours Post-Dose, Absence of Photophobia at 2 Hours Post-Dose, Absence of Phonophobia at 2 Hours Post-Dose and Absence of Nausea at 2 Hours Post-Dose.
Eligibility Criteria
Inclusion Criteria
- Has at least 1 year history of migraine (with or without aura)
- Females of child bearing potential must use acceptable contraception throughout trial.
Exclusion Criteria
- Is pregnant/breast-feeding (or is a female expecting to conceive during study period)
- 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 human immunodeficiency virus (HIV) disease
- Has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
- Has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
- Has a history of cancer within the last 5 years.
Data sourced from ClinicalTrials.gov (NCT00442936). 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.