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

Completed · Phase 3

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT00510419

Run by

Pfizer

People needed

73

Starts

2007-07-01

Expected to finish

2007-12-01

Last updated by the study team

2012-06-08

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• San Francisco Clinical Research Center — San Francisco, California, United States
• New England Center for Headache — Stamford, Connecticut, United States
• Diamond Head Clinic — Chicago, Illinois, United States
• Michigan Head Pain & Neurological Institute — Ann Arbor, Michigan, United States
• Clinvest — Springfield, Missouri, United States
• University of Pittsburgh Headache Center — Pittsburgh, Pennsylvania, United States
• Wesley Headache Clinic — Memphis, Tennessee, United States
• Anodyne Headache and Pain Care — Dallas, Texas, United States
• Houston Headache Clinic — Houston, Texas, United States
• Road Runner Research, LTD — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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