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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510419
• Other study ID #: K644-07-3001
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2007
• Last updated: June 6, 2012
• Start date: July 2007
• Est. completion date: December 2007

Study information

• Verified date: June 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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]

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• "Investigational"Auto-injector (sumatriptan succinate)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	• 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.