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Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-071)

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0462, rizatriptan benzoate / Duration of Treatment -1 day
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)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female patient at least 18 years old Patient has menses approximately monthly Patient has at least a 5 month history of migraine and at least a 6 month history of menstrual migraine Exclusion Criteria: Pregnant and/or nursing Cardiovascular disease Uncontrolled hypertension

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary

    Secondary Outcome Measures

    Percentage of patients with 24-hr sustained pain relief: headache severity between 2 and 24 hrs post dose as recorded in patient diary

    Full Information

    First Posted
    May 24, 2005
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00111709
    Brief Title
    Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-071)
    Official Title
    A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg Tablets for the Treatment of Menstrual Migraine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    May 27, 2005 (Actual)
    Primary Completion Date
    February 24, 2006 (Actual)
    Study Completion Date
    February 26, 2006 (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 a marketed drug in the treatment of a menstrual 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
    393 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0462, rizatriptan benzoate / Duration of Treatment -1 day
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo / Duration of Treatment - 1 day
    Primary Outcome Measure Information:
    Title
    Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary
    Secondary Outcome Measure Information:
    Title
    Percentage of patients with 24-hr sustained pain relief: headache severity between 2 and 24 hrs post dose as recorded in patient diary

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female patient at least 18 years old Patient has menses approximately monthly Patient has at least a 5 month history of migraine and at least a 6 month history of menstrual migraine Exclusion Criteria: Pregnant and/or nursing Cardiovascular disease Uncontrolled hypertension
    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
    17448179
    Citation
    Mannix LK, Loder E, Nett R, Mueller L, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomized, placebo-controlled, double-blind studies. Cephalalgia. 2007 May;27(5):414-21. doi: 10.1111/j.1468-2982.2007.01313.x.
    Results Reference
    background
    PubMed Identifier
    18422606
    Citation
    Nett R, Mannix LK, Mueller L, Rodgers A, Hustad CM, Skobieranda F, Ramsey KE. Rizatriptan efficacy in ICHD-II pure menstrual migraine and menstrually related migraine. Headache. 2008 Sep;48(8):1194-201. doi: 10.1111/j.1526-4610.2008.01093.x. Epub 2008 Apr 14.
    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 a Marketed Drug in the Treatment of Menstrual Migraine (0462-071)

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