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

June 6, 2012 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94109
        • San Francisco Clinical Research Center
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • New England Center for Headache
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Diamond Head Clinic
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Head Pain & Neurological Institute
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Clinvest
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Headache Center
    • Tennessee
      • Memphis, Tennessee, United States, 38018
        • Wesley Headache Clinic
    • Texas
      • Dallas, Texas, United States, 75231
        • Anodyne Headache and Pain Care
      • Houston, Texas, United States, 77004
        • Houston Headache Clinic
      • San Antonio, Texas, United States, 78258
        • Road Runner Research, Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
• 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 1, 2007

First Submitted That Met QC Criteria

August 1, 2007

First Posted (Estimate)

August 2, 2007

Study Record Updates

Last Update Posted (Estimate)

June 8, 2012

Last Update Submitted That Met QC Criteria

June 6, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K644-07-3001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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