ZAP, US. Zomig for Appropriate for Primary Care
Phase 4
Completed
- Conditions
- Migraine
- Registration Number
- NCT00637286
- Lead Sponsor
- AstraZeneca
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in Migraine Disability Assessment questionnaire (MIDAS) score Twice within 28 weeks
- Secondary Outcome Measures
Name Time Method Explore patients assessment of value of zolmitriptan Maximum of 3 times between 1 - 28 weeks