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

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0974 50 mg
MK0974 150 mg
MK0974 300 mg
Comparator: Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    MK0974 50 mg

    MK0974 150 mg

    MK0974 300 mg

    Placebo

    Arm Description

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

    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

    Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose
    Pain Freedom and no migraine-associated symptoms at 2 hours postdose.

    Full Information

    First Posted
    February 5, 2007
    Last Updated
    June 8, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00432237
    Brief Title
    Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    December 2007 (Actual)
    Study Completion Date
    December 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1703 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MK0974 50 mg
    Arm Type
    Experimental
    Arm Description
    MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
    Arm Title
    MK0974 150 mg
    Arm Type
    Experimental
    Arm Description
    MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
    Arm Title
    MK0974 300 mg
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
    Intervention Type
    Drug
    Intervention Name(s)
    MK0974 50 mg
    Other Intervention Name(s)
    MK0974
    Intervention Type
    Drug
    Intervention Name(s)
    MK0974 150 mg
    Other Intervention Name(s)
    MK0974
    Intervention Type
    Drug
    Intervention Name(s)
    MK0974 300 mg
    Other Intervention Name(s)
    MK0974
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.
    Primary Outcome Measure Information:
    Title
    Number of Patients Reporting Pain Freedom at 2 Hours Postdose
    Description
    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.
    Time Frame
    2 hours post dose
    Title
    Number of Patients Reporting Pain Relief at 2 Hours Post Dose
    Description
    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.
    Time Frame
    2 hours post dose
    Title
    Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose
    Description
    Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.
    Time Frame
    2 hours post dose
    Title
    Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose
    Description
    Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.
    Time Frame
    2 hours post dose
    Title
    Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose
    Description
    Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.
    Time Frame
    2 hours post dose
    Secondary Outcome Measure Information:
    Title
    Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose
    Description
    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.
    Time Frame
    2 to 24 hours postdose
    Title
    Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose
    Description
    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.
    Time Frame
    2 to 24 hours postdose
    Title
    Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose
    Description
    Pain Freedom and no migraine-associated symptoms at 2 hours postdose.
    Time Frame
    2 hours postdose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19770473
    Citation
    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.
    Results Reference
    result

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

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