Phase 2
N=420
A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT00246337 ↗Enrolled (actual)
420
Serious AEs
0.3%
Results posted
Sep 2010
Primary outcome: Primary: Pain Relief at 2 Hours — 52; 5; 9; 8 Participants — p=0.015
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Comparator: Placebo (Drug); MK0974 (Drug); Rizatriptan (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Relief at 2 Hours |
52; 5; 9; 8; 5; 25 | 0.015 sig |
| SECONDARY Pain Freedom at 2 Hours |
16; 3; 7; 3; 2; 17 | <0.001 sig |
| SECONDARY Sustained Pain Relief |
27; 1; 9; 3; 3; 20 | <0.001 sig |
| SECONDARY Sustained Pain Freedom |
12; 1; 7; 3; 1; 15 | <0.001 sig |
Summary
The purpose of this study is to investigate the efficacy and safety of an MK 0974 for migraine headache and to identify an appropriate dose range for further study.
Eligibility Criteria
Inclusion Criteria
- Patient has at least 1 year history of migraine (with or without aura)
- Females of childbearing years must use acceptable contraception throughout trial
- Patient is in general good health based on screening assessment
Exclusion Criteria
- Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
- Patient has heart disease, uncontrolled hypertension (high blood pressure), uncontrolled diabetes or other significant disease
- Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other then migraine)
- Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
- Patient has a history of cancer within the last 5 years
Data sourced from ClinicalTrials.gov (NCT00246337). 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.