ZAP, US. Zomig for Appropriate for Primary Care

April 3, 2009 updated by: AstraZeneca

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Migraine Disability Assessment questionnaire (MIDAS) score
Time Frame: Twice within 28 weeks
Twice within 28 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Explore patients assessment of value of zolmitriptan
Time Frame: Maximum of 3 times between 1 - 28 weeks
Maximum of 3 times between 1 - 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

February 8, 2008

First Submitted That Met QC Criteria

March 10, 2008

First Posted (Estimate)

March 17, 2008

Study Record Updates

Last Update Posted (Estimate)

April 6, 2009

Last Update Submitted That Met QC Criteria

April 3, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1223C00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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