A Study to Assess an Auto-Injector Being Used to Treat a Migraine Attack
Information source: King Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: "Investigational"Auto-injector (sumatriptan succinate) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: King Pharmaceuticals
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.
Clinical Details
Official title: A Phase 3 Open-Label Study to Assess Subcutaneous Self-Injection With Sumatriptan Succinate Using an Auto-Injector During a Single Migraine Attack
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Successful administration and acceptability of self-injection of sumatriptan under the skin using an investigational auto-injector will be assessed by use of patient-completed scales and a short questionnaire.
Secondary outcome: • Comparison of pain scores pre-dose and 2 hours post-dose.
• Preference of investigational auto-injector experience compared to subject's previous self-administration of sumatriptan.
Detailed 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]
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Adults 18 to 60 years of age
2. Prior effective use of injectable sumatriptan on at least two occasions within the
last 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 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
Locations and Contacts
San Francisco Clinical Research Center, San Francisco, California 94109, United States
New England Center for Headache, Stamford, Connecticut 06902, United States
Diamond Head Clinic, Chicago, Illinois 60614, United States
Michigan Head Pain & Neurological Institute, Ann Arbor, Michigan 48104, United States
Clinvest, Springfield, Missouri 65807, United States
University of Pittsburgh Headache Center, Pittsburgh, Pennsylvania 15213, United States
Wesley Headache Clinic, Memphis, Tennessee 38018, United States
Anodyne Headache and Pain Care, Dallas, Texas 75231, United States
Houston Headache Clinic, Houston, Texas 77004, United States
Road Runner Research, LTD, San Antonio, Texas 78258, United States
Additional Information
Starting date: July 2007
Ending date: December 2007
Last updated: February 7, 2008
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