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A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)

Primary Purpose

Migraine

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Comparator: Placebo
MK0974
MK0974
MK0974
MK0974
MK0974
MK0974
MK0974
Rizatriptan
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

20 Years - 65 Years (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 Patient is in general good health based on screening assessment Exclusion Criteria: Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period) Patient has heart disease, uncontrolled hypertension (high blood pressure), uncontrolled diabetes or other significant disease Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other then 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 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Placebo

    MK0974 25 mg

    MK0974 50 mg

    MK0974 100 mg

    MK0974 200 mg

    MK0974 300 mg

    MK0974 400 mg

    MK0974 600 mg

    Rizatriptan 10 mg

    Arm Description

    Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.

    MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

    MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

    MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

    MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

    MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

    MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

    MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

    Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

    Outcomes

    Primary Outcome Measures

    Pain Relief at 2 Hours
    Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.

    Secondary Outcome Measures

    Pain Freedom at 2 Hours
    Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain freedom is defined as no pain (Grade 0) at 2 hours post dose.
    Sustained Pain Relief
    Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.
    Sustained Pain Freedom
    Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.

    Full Information

    First Posted
    October 27, 2005
    Last Updated
    October 30, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00246337
    Brief Title
    A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)
    Official Title
    A Multicenter, Double-Blind, Placebo and Active-Controlled, Dose-Finding Study of MK0974 in the Treatment of Acute Migraine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    May 2006 (Actual)
    Study Completion Date
    May 2006 (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 an MK 0974 for migraine headache and to identify an appropriate dose range for further study.

    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 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    420 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
    Arm Title
    MK0974 25 mg
    Arm Type
    Experimental
    Arm Description
    MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
    Arm Title
    MK0974 50 mg
    Arm Type
    Experimental
    Arm Description
    MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
    Arm Title
    MK0974 100 mg
    Arm Type
    Experimental
    Arm Description
    MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
    Arm Title
    MK0974 200 mg
    Arm Type
    Experimental
    Arm Description
    MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
    Arm Title
    MK0974 300 mg
    Arm Type
    Experimental
    Arm Description
    MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
    Arm Title
    MK0974 400 mg
    Arm Type
    Experimental
    Arm Description
    MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
    Arm Title
    MK0974 600 mg
    Arm Type
    Experimental
    Arm Description
    MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
    Arm Title
    Rizatriptan 10 mg
    Arm Type
    Active Comparator
    Arm Description
    Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Placebo to match assigned treatment arm; one orally-administered dose
    Intervention Type
    Drug
    Intervention Name(s)
    MK0974
    Intervention Description
    MK0974 25 mg; one orally-administered dose
    Intervention Type
    Drug
    Intervention Name(s)
    MK0974
    Intervention Description
    MK0974 50 mg; one orally-administered dose
    Intervention Type
    Drug
    Intervention Name(s)
    MK0974
    Intervention Description
    MK0974 100 mg; one orally-administered dose
    Intervention Type
    Drug
    Intervention Name(s)
    MK0974
    Intervention Description
    MK0974 200 mg; one orally-administered dose
    Intervention Type
    Drug
    Intervention Name(s)
    MK0974
    Intervention Description
    MK0974 300 mg; one orally-administered dose
    Intervention Type
    Drug
    Intervention Name(s)
    MK0974
    Intervention Description
    MK0974 400 mg; one orally-administered dose
    Intervention Type
    Drug
    Intervention Name(s)
    MK0974
    Intervention Description
    MK0974 600 mg; one orally-administered dose
    Intervention Type
    Drug
    Intervention Name(s)
    Rizatriptan
    Intervention Description
    Rizatriptan 10 mg; one orally-administered dose
    Primary Outcome Measure Information:
    Title
    Pain Relief at 2 Hours
    Description
    Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.
    Time Frame
    2 hours post dose
    Secondary Outcome Measure Information:
    Title
    Pain Freedom at 2 Hours
    Description
    Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain freedom is defined as no pain (Grade 0) at 2 hours post dose.
    Time Frame
    2 hours post dose
    Title
    Sustained Pain Relief
    Description
    Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.
    Time Frame
    2-24 hours post dose
    Title
    Sustained Pain Freedom
    Description
    Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.
    Time Frame
    2-24 hours post dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 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 Patient is in general good health based on screening assessment Exclusion Criteria: Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period) Patient has heart disease, uncontrolled hypertension (high blood pressure), uncontrolled diabetes or other significant disease Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other then 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
    17914062
    Citation
    Ho TW, Mannix LK, Fan X, Assaid C, Furtek C, Jones CJ, Lines CR, Rapoport AM; MK-0974 Protocol 004 study group. Randomized controlled trial of an oral CGRP receptor antagonist, MK-0974, in acute treatment of migraine. Neurology. 2008 Apr 15;70(16):1304-12. doi: 10.1212/01.WNL.0000286940.29755.61. Epub 2007 Oct 3.
    Results Reference
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    A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)

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