ZAP, US. Zomig for Appropriate for Primary Care

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Migraine

Treatments: Drug: Zolmitriptan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00637286

D1223C00002

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)