ZAP, US. Zomig for Appropriate for Primary Care

NCT ID: NCT00637286

Last Updated: 2009-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2005-05-31

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

Conditions

Migraine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Zolmitriptan

5mg Nasal Spray

Intervention Type: DRUG

Other Intervention Names

Zomig

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Other Identifiers

D1223C00002

Identifier Type: -

Identifier Source: org_study_id