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

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]

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