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

Last updated on November 11, 2019

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

NCT00510419
Pfizer
Completed
A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack

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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 DateDecember 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 CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS AccountPfizer
Verification DateJune 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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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

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