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

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
"Investigational"Auto-injector (sumatriptan succinate)
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Francisco Clinical Research Center
  • New England Center for Headache
  • Diamond Head Clinic
  • Michigan Head Pain & Neurological Institute
  • Clinvest
  • University of Pittsburgh Headache Center
  • Wesley Headache Clinic
  • Anodyne Headache and Pain Care
  • Houston Headache Clinic
  • Road Runner Research, LTD

Outcomes

Primary Outcome Measures

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

• 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.

Full Information

First Posted
August 1, 2007
Last Updated
June 6, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00510419
Brief Title
A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack
Official Title
A Phase 3 Open-Label Study to Assess Subcutaneous Self-Injection With Sumatriptan Succinate Using an Auto-injector During a Single Migraine Attack
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Investigational Plan: Screening Visit [Visit 0 / 0-14 days prior to receipt of study drug] Baseline Visit [Visit 1 / Provision of study drug and subject training] Treatment Visit [Visit 2 / within 72 hours after study drug administration] Follow-up Visit [Visit 3 / Telephone follow-up 7-10 days after study drug administration]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
"Investigational"Auto-injector (sumatriptan succinate)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
• 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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Facility Information:
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
New England Center for Headache
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Diamond Head Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Michigan Head Pain & Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Clinvest
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
University of Pittsburgh Headache Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Wesley Headache Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Anodyne Headache and Pain Care
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Houston Headache Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Road Runner Research, LTD
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23148799
Citation
Landy SH, Tepper SJ, Wein T, Schweizer E, Ramos E. An open-label trial of a sumatriptan auto-injector for migraine in patients currently treated with subcutaneous sumatriptan. Headache. 2013 Jan;53(1):118-125. doi: 10.1111/j.1526-4610.2012.02295.x. Epub 2012 Nov 13.
Results Reference
derived

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

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