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ZAP, US. Zomig for Appropriate for Primary Care

Primary Purpose

Migraine

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Zolmitriptan
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Zolmitriptan, ZOMIG, migraine, headache response, headache, headache pain, MIDAS, HCPC

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have an established diagnose of migraine as with an age at onset of less than 50 years
  • Have experienced an average of at least 1 migraine headache per month in the previous three months
  • Be able to differentiate between migraine and non-migraine headaches

Exclusion Criteria:

  • Use of any triptan within the last 12 months or use of MAO-A inhibitors, methysergide or methylergonovine in the 2 weeks before entering the study.
  • History of basilar, ophthalmoplegic or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache
  • History, symptoms, or significant risk factors for ischaemic heart or other cardiovascular disease, including coronary vasospasm, cardiac accessory conduction pathways or arrhythmias or uncontrolled hypertension.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change in Migraine Disability Assessment questionnaire (MIDAS) score

    Secondary Outcome Measures

    Explore patients assessment of value of zolmitriptan

    Full Information

    First Posted
    February 8, 2008
    Last Updated
    April 3, 2009
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00637286
    Brief Title
    ZAP, US. Zomig for Appropriate for Primary Care
    Official Title
    A Multicenter, Open-Label Study Using the MIDAS Questionnaire to Assess the Effect of Using the HCPC Guidelines for Migraine Management in Primary Care, Including the Use of Zomig-ZMT (Zolmitriptan) Orally Disintegrating Tablets 5.0mg and Zomig Nasal Spray 5.0mg as Indicated.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine how useful and effective the use of ZOMIG-ZMT™ (zolmitriptan) 5.0 mg and ZOMIG® Nasal Spray (zolmitriptan) 5.0 mg is for patients, in treating migraine over a period of 6 months

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine
    Keywords
    Zolmitriptan, ZOMIG, migraine, headache response, headache, headache pain, MIDAS, HCPC

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Zolmitriptan
    Other Intervention Name(s)
    Zomig
    Intervention Description
    5mg Nasal Spray
    Primary Outcome Measure Information:
    Title
    Change in Migraine Disability Assessment questionnaire (MIDAS) score
    Time Frame
    Twice within 28 weeks
    Secondary Outcome Measure Information:
    Title
    Explore patients assessment of value of zolmitriptan
    Time Frame
    Maximum of 3 times between 1 - 28 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have an established diagnose of migraine as with an age at onset of less than 50 years Have experienced an average of at least 1 migraine headache per month in the previous three months Be able to differentiate between migraine and non-migraine headaches Exclusion Criteria: Use of any triptan within the last 12 months or use of MAO-A inhibitors, methysergide or methylergonovine in the 2 weeks before entering the study. History of basilar, ophthalmoplegic or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache History, symptoms, or significant risk factors for ischaemic heart or other cardiovascular disease, including coronary vasospasm, cardiac accessory conduction pathways or arrhythmias or uncontrolled hypertension.

    12. IPD Sharing Statement

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