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

Merck Sharp & Dohme LLC420 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

420

Conditions

Migraine

Interventions

Comparator: PlaceboDRUG

Placebo to match assigned treatment arm; one orally-administered dose

MK0974DRUG

MK0974 25 mg; one orally-administered dose

MK0974DRUG

MK0974 50 mg; one orally-administered dose

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pain Relief at 2 Hours

Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.

Time frame: 2 hours post dose

Secondary Outcomes

Pain Freedom at 2 Hours

Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain freedom is defined as no pain (Grade 0) at 2 hours post dose.

Time frame: 2 hours post dose

Sustained Pain Relief

Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.

Time frame: 2-24 hours post dose

Sustained Pain Freedom

Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.

Time frame: 2-24 hours post dose

Data from ClinicalTrials.gov

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