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

Phase 3

Completed

• Conditions: Migraine

• Registration Number: NCT00510419
• Lead Sponsor: Pfizer

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.

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

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-01
• Study First Submitted QC: 2007-08-01
• Study First Posted: 2007-08-02
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
• 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.

Trial Locations

Locations (10)

New England Center for Headache; 🇺🇸 Stamford, Connecticut, United States

Diamond Head Clinic; 🇺🇸 Chicago, Illinois, United States

Clinvest; 🇺🇸 Springfield, Missouri, United States

Anodyne Headache and Pain Care; 🇺🇸 Dallas, Texas, United States

Wesley Headache Clinic; 🇺🇸 Memphis, Tennessee, United States

San Francisco Clinical Research Center; 🇺🇸 San Francisco, California, United States

University of Pittsburgh Headache Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Michigan Head Pain & Neurological Institute; 🇺🇸 Ann Arbor, Michigan, United States

Houston Headache Clinic; 🇺🇸 Houston, Texas, United States

Road Runner Research, LTD; 🇺🇸 San Antonio, Texas, United States