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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00510419
First received: August 1, 2007
Last updated: June 6, 2012
Last verified: June 2012

August 1, 2007
June 6, 2012
July 2007
December 2007   (final data collection date for primary 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.
Same as current
Complete list of historical versions of study NCT00510419 on ClinicalTrials.gov Archive Site
• 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.
Same as current
Not Provided
Not Provided
 
A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack
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.

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]
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Migraine
Drug: "Investigational"Auto-injector (sumatriptan succinate)
Not Provided
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):118-25. 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.
 
Completed
73
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00510419
K644-07-3001
Yes
Not Provided
Pfizer
Not Provided
Not Provided
Pfizer
June 2012

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