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

NCT00510419

Last updated date
Study Location
San Francisco Clinical Research Center
San Francisco, California, 94109, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Migraine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack
Official Title  ICMJE A Phase 3 Open-Label Study to Assess Subcutaneous Self-Injection With Sumatriptan Succinate Using an Auto-injector During a Single Migraine Attack
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:

  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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE Drug: "Investigational"Auto-injector (sumatriptan succinate)
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2008)
73
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2007)
75
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00510419
Other Study ID Numbers  ICMJE K644-07-3001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pfizer
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP