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

Phase 3

Completed

• Conditions: Migraine
• Interventions: Drug: MK0974 50 mg; Drug: MK0974 150 mg; Drug: MK0974 300 mg

• Registration Number: NCT00432237
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2007-02-05
• Study First Submitted QC: 2007-02-05
• Study First Posted: 2007-02-07
• Study Start: 2007-03
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2010-07-19
• Results First Submitted QC: 2010-11-03
• Results First Posted: 2010-12-06
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1703

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK0974 50 mg	MK0974 50 mg	MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
MK0974 150 mg	MK0974 150 mg	MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
MK0974 300 mg	MK0974 300 mg	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

Primary Outcome Measures

Name	Time	Method
Number of Patients Reporting Pain Freedom at 2 Hours Postdose	2 hours post dose	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.
Number of Patients Reporting Pain Relief at 2 Hours Post Dose	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.
Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose	2 hours post dose	Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.
Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose	2 hours post dose	Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.
Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose	2 hours post dose	Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose	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.
Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose	2 to 24 hours postdose	Pain Freedom and no migraine-associated symptoms at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache or migraine-associated symptom during the 24 hours after dosing with study medication.
Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose	2 hours postdose	Pain Freedom and no migraine-associated symptoms at 2 hours postdose.