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Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: rizatriptan benzoate
Comparator: Placebo
Sponsored by
Organon and Co
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:

  • Greater than one year history of migraine
  • Attacks typically mild when they begin and progress to moderate or severe
  • Experience 1-4 migraine attacks per month

Exclusion Criteria:

  • More than 15 headache days per month
  • Heart disease
  • Uncontrolled high blood pressure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Active Drug

    Matching Pbo Comparator

    Outcomes

    Primary Outcome Measures

    Number of Participants Who Are Pain Free at 2 Hours Post-Dose
    Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.

    Secondary Outcome Measures

    Number of Participants With 24-Hour Sustained Pain Freedom
    24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.
    Number of Participants With no Rescue Use up to 24 Hours Post-Dose
    Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.
    Number of Participants With Absence of Photophobia at 2 Hours Post-dose
    Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.
    Number of Participants With Absence of Phonophobia at 2 Hours Post-dose
    Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.
    Number of Participants With Absence of Nausea at 2 Hours Post-dose
    Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.
    Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose
    Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose.

    Full Information

    First Posted
    August 13, 2007
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00516737
    Brief Title
    Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)
    Official Title
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    October 3, 2007 (Actual)
    Primary Completion Date
    April 8, 2008 (Actual)
    Study Completion Date
    April 8, 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.

    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
    207 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Active Drug
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Matching Pbo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: rizatriptan benzoate
    Other Intervention Name(s)
    MK0462
    Intervention Description
    Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Matching placebo; one dose, treatment of a single migraine attack
    Primary Outcome Measure Information:
    Title
    Number of Participants Who Are Pain Free at 2 Hours Post-Dose
    Description
    Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.
    Time Frame
    2 hours post-dose
    Secondary Outcome Measure Information:
    Title
    Number of Participants With 24-Hour Sustained Pain Freedom
    Description
    24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.
    Time Frame
    24 hours post-dose
    Title
    Number of Participants With no Rescue Use up to 24 Hours Post-Dose
    Description
    Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.
    Time Frame
    24 hours post-dose
    Title
    Number of Participants With Absence of Photophobia at 2 Hours Post-dose
    Description
    Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.
    Time Frame
    2 hours post-dose
    Title
    Number of Participants With Absence of Phonophobia at 2 Hours Post-dose
    Description
    Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.
    Time Frame
    2 hours post-dose
    Title
    Number of Participants With Absence of Nausea at 2 Hours Post-dose
    Description
    Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.
    Time Frame
    2 hours post-dose
    Title
    Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose
    Description
    Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose.
    Time Frame
    2 hours post-dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Greater than one year history of migraine Attacks typically mild when they begin and progress to moderate or severe Experience 1-4 migraine attacks per month Exclusion Criteria: More than 15 headache days per month Heart disease Uncontrolled high blood pressure
    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

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    19472447
    Citation
    Cady RK, Martin VT, Geraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96. doi: 10.1111/j.1526-4610.2009.01412.x.
    Results Reference
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    Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)

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