Phase 3 N=1,703 Randomized Double-blind Treatment

Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)

Migraine

Bottom Line

View on ClinicalTrials.gov: NCT00432237 ↗

Enrolled (actual)

1,703

Serious AEs

0.2%

Results posted

Dec 2010

Primary outcome: Primary: Number of Patients Reporting Pain Freedom at 2 Hours Postdose — 29; 88; 88; 39 Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: MK0974 50 mg (Drug); MK0974 150 mg (Drug); MK0974 300 mg (Drug); Comparator: Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Dec 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Reporting Pain Freedom at 2 Hours Postdose	29; 88; 88; 39	<0.001 sig
PRIMARY Number of Patients Reporting Pain Relief at 2 Hours Post Dose	78; 205; 205; 120	<0.001 sig
PRIMARY Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose	72; 176; 179; 119	<0.001 sig
PRIMARY Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose	85; 192; 206; 152	<0.001 sig
PRIMARY Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose	113; 260; 258; 196	<0.001 sig
SECONDARY Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose	25; 62; 63; 26	<0.001 sig
SECONDARY Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose	20; 55; 54; 23	<0.001 sig
SECONDARY Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose	24; 78; 78; 36	<0.001 sig

Summary

The purpose of this study is to investigate the efficacy and safety of MK0974 compared to a placebo for acute migraine.

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

Exclusion Criteria

Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
Patient has history or evidence of uncontrolled diabetes, or Human Immunodeficiency Virus (HIV) disease. Patient has uncontrolled cardiovascular disease
Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00432237). 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.