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...
Date First Received: August 1, 2007
Last Updated: February 7, 2008
Verified by: King Pharmaceuticals, February 2008
Clinical Trial Phase: Phase 3 | Start Date: July 2007
Overall Status: Completed
Estimated Enrollment: 73
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Detailed Clinical Trial 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]
Outcome Measures for this Clinical Trial
Primary:
- 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:
- • 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.
Criteria for Participation in this Clinical Trial
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
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: King Pharmaceuticals
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
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00510419
Study ID Number: K644-07-3001
ClinicalTrials.gov Identifier: NCT00510419
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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