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

A Phase III, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Oral MK0974 in the Acute Treatment of Migraine With or Without Aura

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

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: MK0974 50 mg; Drug: MK0974 150 mg; Drug: MK0974 300 mg; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1703
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: MK0974 50 mg; Other Names: MK0974
Experimental: 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	Drug: MK0974 150 mg; Other Names: MK0974
Experimental: 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	Drug: MK0974 300 mg; Other Names: MK0974
Placebo Comparator: Placebo; Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack	Drug: Comparator: Placebo; MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	2 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 to 24 hours postdose
Number of Patients Who Have Total Migraine Freedom 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.	2 to 24 hours postdose
Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose	Pain Freedom and no migraine-associated symptoms at 2 hours postdose.	2 hours postdose

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Connor KM, Shapiro RE, Diener HC, Lucas S, Kost J, Fan X, Fei K, Assaid C, Lines C, Ho TW. Randomized, controlled trial of telcagepant for the acute treatment of migraine. Neurology. 2009 Sep 22;73(12):970-7. doi: 10.1212/WNL.0b013e3181b87942.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: February 5, 2007
• First Submitted That Met QC Criteria: February 5, 2007
• First Posted (Estimate): February 7, 2007

Study Record Updates

• Last Update Posted (Estimate): July 3, 2015
• Last Update Submitted That Met QC Criteria: June 8, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 0974-016; 2006_526