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A Phase 3 Open-Label Study to Assess Subcutaneous Self-Injection With Sumatriptan Succinate Using an Auto-injector During a Single Migraine Attack
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.
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 \[Visit 3 / Telephone follow-up 7-10 days after study drug administration\]
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
San Francisco Clinical Research Center
San Francisco, California, United States
New England Center for Headache
Stamford, Connecticut, United States
Diamond Head Clinic
Chicago, Illinois, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States
Clinvest
Springfield, Missouri, United States
University of Pittsburgh Headache Center
Pittsburgh, Pennsylvania, United States
Wesley Headache Clinic
Memphis, Tennessee, United States
Anodyne Headache and Pain Care
Dallas, Texas, United States
Houston Headache Clinic
Houston, Texas, United States
Road Runner Research, LTD
San Antonio, Texas, United States
Start Date
July 1, 2007
Primary Completion Date
December 1, 2007
Completion Date
December 1, 2007
Last Updated
June 8, 2012
73
ACTUAL participants
"Investigational"Auto-injector (sumatriptan succinate)
DRUG
Lead Sponsor
Pfizer
NCT06641466
NCT07018713
NCT04715685
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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