ZAP, US. Zomig for Appropriate for Primary Care

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00637286

Enrollment

120

Registered

2008-03-17

Start date

2004-07-31

Completion date

2005-05-31

Last updated

2009-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Zolmitriptan, ZOMIG, migraine, headache response, headache, headache pain, MIDAS, HCPC

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

Interventions

DRUGZolmitriptan

5mg Nasal Spray

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Change in Migraine Disability Assessment questionnaire (MIDAS) score	Twice within 28 weeks

Secondary

Measure	Time frame
Explore patients assessment of value of zolmitriptan	Maximum of 3 times between 1 - 28 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026