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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Investigational"Auto-injector (sumatriptan succinate) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| • 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Clinical Research Center | San Francisco | California | 94109 | United States | ||
| New England Center for Headache |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23148799 | Derived | 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. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Stamford |
| Connecticut |
| 06902 |
| United States |
| Diamond Head Clinic | Chicago | Illinois | 60614 | United States |
| Michigan Head Pain & Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| Clinvest | Springfield | Missouri | 65807 | United States |
| University of Pittsburgh Headache Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Wesley Headache Clinic | Memphis | Tennessee | 38018 | United States |
| Anodyne Headache and Pain Care | Dallas | Texas | 75231 | United States |
| Houston Headache Clinic | Houston | Texas | 77004 | United States |
| Road Runner Research, LTD | San Antonio | Texas | 78258 | United States |
| D009422 | Nervous System Diseases |
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |