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

Pfizer73 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Migraine

Interventions

"Investigational"Auto-injector (sumatriptan succinate)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (10)

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

Outcomes

Primary Outcomes

Successful administration and acceptability of self-injection of sumatriptan under the skin using an investigational auto-injector will be assessed by use of patient-completed scales and a short questionnaire.

Secondary Outcomes

• Comparison of pain scores pre-dose and 2 hours post-dose. • Preference of investigational auto-injector experience compared to subject's previous self-administration of sumatriptan.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.