A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack
NCT00510419
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Adult Trials: 18+ Years
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)
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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| 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:
| ||
| 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 | 73 | ||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| ||
| Sex/Gender ICMJE |
| ||
| 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 | |||