ZAP, US. Zomig for Appropriate for Primary Care

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: February 8, 2008
Last updated: April 3, 2009
Last verified: April 2009

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

Condition Intervention Phase
Drug: Zolmitriptan
Phase 4

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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in Migraine Disability Assessment questionnaire (MIDAS) score [ Time Frame: Twice within 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Explore patients assessment of value of zolmitriptan [ Time Frame: Maximum of 3 times between 1 - 28 weeks ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: July 2004
Study Completion Date: May 2005
Intervention Details:
    Drug: Zolmitriptan
    5mg Nasal Spray
    Other Name: Zomig

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided Identifier: NCT00637286     History of Changes
Other Study ID Numbers: D1223C00002
Study First Received: February 8, 2008
Last Updated: April 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by AstraZeneca:
headache response
headache pain

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin Agents
Serotonin Receptor Agonists processed this record on October 23, 2014