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Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00510419
Study type Interventional
Source Pfizer
Contact
Status Completed
Phase Phase 3
Start date July 2007
Completion date December 2007

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