ZAP, US. Zomig for Appropriate for Primary Care

Verified by: AstraZeneca, April 2009
First Received: February 8, 2008 | Last Updated: April 3, 2009 | Phase: Phase 4 | Start Date: July 2004
Overall Status: Completed | Estimated Enrollment: 120
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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...

Brief Summary

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.”

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 Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Drug: Zolmitriptan
    • 5mg Nasal Spray

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in Migraine Disability Assessment questionnaire (MIDAS) score
    • Time Frame: Twice within 28 weeks
      Safety Issue?: No

Secondary Measures

  • Explore patients assessment of value of zolmitriptan
    • Time Frame: Maximum of 3 times between 1 - 28 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: AstraZeneca Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00637286

Study ID Number: D1223C00002

ClinicalTrials.gov Identifier: NCT00637286

Health Authority: United States: Institutional Review Board

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00637286