ZAP, US. Zomig for Appropriate for Primary Care - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00637286

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 IV

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Zolmitriptan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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.

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:

5mg Nasal Spray

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

Study ID Numbers:	D1223C00002
Study First Received:	February 8, 2008
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00637286 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by AstraZeneca:

Zolmitriptan
ZOMIG
migraine
headache response

headache
headache pain
MIDAS
HCPC

Study placed in the following topic categories:

Serotonin Agonists
Neurotransmitter Agents
Zolmitriptan
Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Pain
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Zolmitriptan
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Pharmacologic Actions
Headache Disorders
Serotonin Agents
Migraine Disorders

ClinicalTrials.gov processed this record on May 07, 2009