A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Migraine

Treatments: Drug: MK0974; Drug: Rizatriptan; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00246337

0974-004

2005_082

Details and patient eligibility

About

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.

Enrollment: 420 patients

Sex: All

Ages: 20 to 65 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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420 participants in 9 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.

Treatment:

Drug: Comparator: Placebo

MK0974 25 mg

Experimental group

Description:

MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

Treatment:

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

MK0974 50 mg

Experimental group

Description:

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

Treatment:

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

MK0974 100 mg

Experimental group

Description:

MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

Treatment:

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

MK0974 200 mg

Experimental group

Description:

MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

Treatment:

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

MK0974 300 mg

Experimental group

Description:

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

Treatment:

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

MK0974 400 mg

Experimental group

Description:

MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

Treatment:

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

MK0974 600 mg

Experimental group

Description:

MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

Treatment:

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Drug: MK0974

Rizatriptan 10 mg

Active Comparator group

Description:

Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

Treatment:

Drug: Rizatriptan