ZAP, US. Zomig for Appropriate for Primary Care

Migraine Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637286
• Other study ID #: D1223C00002
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2008
• Last updated: April 3, 2009
• Start date: July 2004
• Est. completion date: May 2005

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Zolmitriptan
5mg Nasal Spray

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Migraine Disability Assessment questionnaire (MIDAS) score		Twice within 28 weeks	No
Secondary	Explore patients assessment of value of zolmitriptan		Maximum of 3 times between 1 - 28 weeks	No