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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Comparator: Placebo; Drug: MK0974 150 mg; Drug: MK0974 50 mg; Drug: MK0974 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00432237

2006_526

0974-016

Details and patient eligibility

About

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

Enrollment: 1,703 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,703 participants in 4 patient groups, including a placebo group

MK0974 50 mg

Experimental group

Description:

MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack

Treatment:

Drug: MK0974 50 mg

MK0974 150 mg

Experimental group

Description:

MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack

Treatment:

Drug: MK0974 150 mg

MK0974 300 mg

Experimental group

Description:

MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack

Treatment:

Drug: MK0974 300 mg

Placebo

Placebo Comparator group

Description:

Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack

Treatment:

Drug: Comparator: Placebo