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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 1, 2007
Last Updated Date	June 6, 2012
Start Date ^ICMJE	July 2007
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 1, 2007)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00510419 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 1, 2007)	• 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

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: 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]
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Migraine
Intervention ^ICMJE	Drug: "Investigational"Auto-injector (sumatriptan succinate)
Study Arm (s)	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):118-25. 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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	73
Completion Date	December 2007
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00510419
Other Study ID Numbers ^ICMJE	K644-07-3001
Has Data Monitoring Committee	Yes
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Pfizer
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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