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

Phase 3CompletedNCT00432237

Merck Sharp & Dohme LLC1,703 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,703

Conditions

Migraine

Interventions

MK0974 50 mgDRUG

MK0974 150 mgDRUG

MK0974 300 mgDRUG

Comparator: PlaceboDRUG

MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.

Eligibility

Sex: ALLMin age: 18 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 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

Outcomes

Primary Outcomes

Number of Patients Reporting Pain Freedom at 2 Hours Postdose

Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.

Time frame: 2 hours post dose

Number of Patients Reporting Pain Relief at 2 Hours Post Dose

Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.

Time frame: 2 hours post dose

Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose

Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.

Time frame: 2 hours post dose

Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose

Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.

Time frame: 2 hours post dose

Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose

Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.

Time frame: 2 hours post dose

Secondary Outcomes

Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose

Pain Freedom at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 24 hours after dosing with study medication.

Data from ClinicalTrials.gov

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