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
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 April 17, 2014