A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack
A Phase 3 Open-Label Study to Assess Subcutaneous Self-Injection With Sumatriptan Succinate Using an Auto-injector During a Single Migraine Attack
1 other identifier
interventional
73
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2007
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 1, 2007
CompletedFirst Posted
Study publicly available on registry
August 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJune 8, 2012
June 1, 2012
5 months
August 1, 2007
June 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
• 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.
Interventions
Eligibility Criteria
You may qualify if:
- Adults 18 to 60 years of age
- Prior effective use of injectable sumatriptan on at least two occasions within the last two months
- At least two migraines per month suitable injectable sumatriptan
- Capable of using a migraine self-injection auto-injector
- Capable of distinguishing between migraine and other headache types (e.g., tension-type headache)
You may not qualify if:
- Seizure disorders
- Coronary artery disease (CAD)
- Cardiac dysrhythmia or pacemaker
- High blood pressure
- Liver disease
- Kidney disease
- Autoimmune disease
- History of alcohol or substance abuse
- Currently pregnant
- Use of any other investigational drug product within 30 days prior to treatment visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (10)
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
Related Publications (1)
Landy SH, Tepper SJ, Wein T, Schweizer E, Ramos E. An open-label trial of a sumatriptan auto-injector for migraine in patients currently treated with subcutaneous sumatriptan. Headache. 2013 Jan;53(1):118-125. doi: 10.1111/j.1526-4610.2012.02295.x. Epub 2012 Nov 13.
PMID: 23148799DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 1, 2007
First Posted
August 2, 2007
Study Start
July 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
June 8, 2012
Record last verified: 2012-06