Skip to main content
OpenTrials
Completed

NCT Number: NCT00432237

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0974 50 mg

Drug

Other names: MK0974

MK0974 150 mg

Drug

Other names: MK0974

MK0974 300 mg

Drug

Other names: MK0974

Comparator: placebo

Drug

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

Primary outcomes

  1. Number of Patients Reporting Pain Freedom at 2 Hours Postdose

    Time frame: 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.

  2. Number of Patients Reporting Pain Relief at 2 Hours Post Dose

    Time frame: 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.

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

    Time frame: 2 hours post dose

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

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

    Time frame: 2 hours post dose

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

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

    Time frame: 2 hours post dose

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

Secondary outcomes

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

    Time frame: 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. Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose

    Time frame: 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.

  3. Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose

    Time frame: 2 hours postdose

    Pain Freedom and no migraine-associated symptoms at 2 hours postdose.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 7, 2007
Registry last updated
Jul 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.