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COMPLETEDPhase 3NCT00510419

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

Lead sponsor: Pfizer•10 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Pfizer

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

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 8, 2012Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment73

Start dateJul 2007

Last updatedJun 8, 2012

Condition

Locations shown

San Francisco Clinical Research Center

San Francisco, California

New England Center for Headache

Stamford, Connecticut

Diamond Head Clinic

Chicago, Illinois

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2012Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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