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Study to Test an Approved Product in the Early Treatment of Migraine (0462-066)

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0462, rizatriptan benzoate / Duration of Treatment: 1day
Comparator: placebo / Duration of Treatment: 1 day
Sponsored by
Organon and Co
About
Eligibility
Locations
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: Six month history of migraine; attacks typically mild when they begin with 1-4 migraine attacks per month. Exclusion Criteria: Heart disease High blood pressure

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Percentage of patients who are pain free at 2 hours postdose
    Tolerability as measured by subjective adverse experience reporting

    Secondary Outcome Measures

    Percentage of patients with 24 hour sustained pain freedom
    Percentage of patients pain free at 30/45/60/90 minutes post dose
    Percentage of patients with associated symptoms at 2 hours
    Percentage of patients requiring rescue medication between 2 & 24 hours
    Percentage of patients with functional disability at 2 hours

    Full Information

    First Posted
    October 29, 2004
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00095004
    Brief Title
    Study to Test an Approved Product in the Early Treatment of Migraine (0462-066)
    Official Title
    A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Examine the Efficacy of Rizatriptan 10 mg Tablet Administered Early During a Migraine Attack While the Pain is Mild
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    October 21, 2004 (Actual)
    Primary Completion Date
    April 1, 2005 (Actual)
    Study Completion Date
    April 4, 2005 (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 an approved drug in the early treatment of 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
    167 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0462, rizatriptan benzoate / Duration of Treatment: 1day
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo / Duration of Treatment: 1 day
    Primary Outcome Measure Information:
    Title
    Percentage of patients who are pain free at 2 hours postdose
    Title
    Tolerability as measured by subjective adverse experience reporting
    Secondary Outcome Measure Information:
    Title
    Percentage of patients with 24 hour sustained pain freedom
    Title
    Percentage of patients pain free at 30/45/60/90 minutes post dose
    Title
    Percentage of patients with associated symptoms at 2 hours
    Title
    Percentage of patients requiring rescue medication between 2 & 24 hours
    Title
    Percentage of patients with functional disability at 2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Six month history of migraine; attacks typically mild when they begin with 1-4 migraine attacks per month. Exclusion Criteria: Heart disease 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

    Citations:
    PubMed Identifier
    16732837
    Citation
    Cady R, Martin V, Mauskop A, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of Rizatriptan 10 mg administered early in a migraine attack. Headache. 2006 Jun;46(6):914-24. doi: 10.1111/j.1526-4610.2006.00466.x.
    Results Reference
    background
    PubMed Identifier
    18005144
    Citation
    Martin V, Cady R, Mauskop A, Seidman LS, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of rizatriptan for menstrual migraine in an early intervention model: a prospective subgroup analysis of the rizatriptan TAME (Treat A Migraine Early) studies. Headache. 2008 Feb;48(2):226-35. doi: 10.1111/j.1526-4610.2007.00947.x. Epub 2007 Nov 13.
    Results Reference
    background
    PubMed Identifier
    17681023
    Citation
    Cady R, Martin V, Mauskop A, Rodgers A, Hustad C, Ramsey K, Skobieranda F. Symptoms of cutaneous sensitivity pre-treatment and post-treatment: results from the rizatriptan TAME studies. Cephalalgia. 2007 Sep;27(9):1055-60. doi: 10.1111/j.1468-2982.2007.01391.x. Epub 2007 Aug 6.
    Results Reference
    background
    PubMed Identifier
    19222588
    Citation
    Ho TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. doi: 10.1111/j.1526-4610.2009.01346.x. Epub 2008 Feb 12.
    Results Reference
    background
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Study to Test an Approved Product in the Early Treatment of Migraine (0462-066)

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