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

Tracking Information
First Received Date ^ICMJE	August 1, 2007
Last Updated Date	October 27, 2009
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

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 Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Condition ^ICMJE	Migraine
Intervention ^ICMJE	Drug: "Investigational"Auto-injector (sumatriptan succinate)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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 ID ^ICMJE	NCT00510419
Responsible Party
Study ID Numbers ^ICMJE	K644-07-3001
Study Sponsor ^ICMJE	King Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	King Pharmaceuticals
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP