A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack

Last updated: June 6, 2012
Sponsor: Pfizer
Overall Status: Completed

Phase

3

Condition

Pain (Pediatric)

Pain

Headaches

Treatment

N/A

Clinical Study ID

NCT00510419
K644-07-3001
  • Ages 18-60
  • All Genders

Study Summary

The purpose of this research study is to evaluate an investigational auto-injector system for delivering sumatriptan under the skin for a single migraine attack.

The study could take approximately 5 weeks and will include about 3 office visits to the study doctor, the patient will be contacted every 2 weeks until the patient experiences a migraine and uses the auto-injector. The last visit will be done by a telephone follow-up call.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults 18 to 60 years of age

  2. Prior effective use of injectable sumatriptan on at least two occasions within thelast two months

  3. At least two migraines per month suitable injectable sumatriptan

  4. Capable of using a migraine self-injection auto-injector

  5. Capable of distinguishing between migraine and other headache types (e.g.,tension-type headache)

Exclusion

Exclusion Criteria:

  1. Seizure disorders

  2. Coronary artery disease (CAD)

  3. Cardiac dysrhythmia or pacemaker

  4. High blood pressure

  5. Liver disease

  6. Kidney disease

  7. Autoimmune disease

  8. History of alcohol or substance abuse

  9. Currently pregnant

  10. Use of any other investigational drug product within 30 days prior to treatment visit

Study Design

Total Participants: 73
Study Start date:
July 01, 2007
Estimated Completion Date:
December 31, 2007

Study Description

Investigational Plan:

  1. Screening Visit [Visit 0 / 0-14 days prior to receipt of study drug]

  2. Baseline Visit [Visit 1 / Provision of study drug and subject training]

  3. Treatment Visit [Visit 2 / within 72 hours after study drug administration]

  4. Follow-up Visit [Visit 3 / Telephone follow-up 7-10 days after study drug administration]

Connect with a study center

  • San Francisco Clinical Research Center

    San Francisco, California 94109
    United States

    Site Not Available

  • New England Center for Headache

    Stamford, Connecticut 06902
    United States

    Site Not Available

  • Diamond Head Clinic

    Chicago, Illinois 60614
    United States

    Site Not Available

  • Michigan Head Pain & Neurological Institute

    Ann Arbor, Michigan 48104
    United States

    Site Not Available

  • Clinvest

    Springfield, Missouri 65807
    United States

    Site Not Available

  • University of Pittsburgh Headache Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Wesley Headache Clinic

    Memphis, Tennessee 38018
    United States

    Site Not Available

  • Anodyne Headache and Pain Care

    Dallas, Texas 75231
    United States

    Site Not Available

  • Houston Headache Clinic

    Houston, Texas 77004
    United States

    Site Not Available

  • Road Runner Research, LTD

    San Antonio, Texas 78258
    United States

    Site Not Available

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