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: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Zolmitriptan
  • 5mg Nasal Spray

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

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

Lead Sponsor: AstraZeneca

Information obtained from ClinicalTrials.gov on July 02, 2009

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