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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00432237
First received: February 5, 2007
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Migraine
Drug: MK0974 50 mg
Drug: MK0974 150 mg
Drug: MK0974 300 mg
Drug: Comparator: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Patients Reporting Pain Freedom at 2 Hours Postdose [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]

    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 [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]

    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 [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
    Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.


Secondary Outcome Measures:
  • Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose [ Time Frame: 2 to 24 hours postdose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 to 24 hours postdose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 hours postdose ] [ Designated as safety issue: No ]
    Pain Freedom and no migraine-associated symptoms at 2 hours postdose.


Enrollment: 1703
Study Start Date: March 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432237

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00432237     History of Changes
Other Study ID Numbers: 0974-016, 2006_526
Study First Received: February 5, 2007
Results First Received: July 19, 2010
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014