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ZAP, US. Zomig for Appropriate for Primary Care

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00637286
First received: February 8, 2008
Last updated: April 3, 2009
Last verified: April 2009
History of Changes
  Purpose

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
Migraine
 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:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov 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:
Zolmitriptan
ZOMIG
migraine
headache response
 headache
headache pain
MIDAS
HCPC

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Zolmitriptan
Oxazolidinones
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
 Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Infective Agents
Therapeutic Uses
Protein Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013