ZAP, US. Zomig for Appropriate for Primary Care

Overview

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

Full Title of Study: “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

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

Interventions

  • Drug: Zolmitriptan
    • 5mg Nasal Spray

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Explore patients assessment of value of zolmitriptan
    • Time Frame: Maximum of 3 times between 1 – 28 weeks

Participating 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: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca

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