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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Sumatriptan

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