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Long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months post injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Group | STX-015-18-01 Clonidine Micropellet long-term safety follow-up |
| |
| Sham Control | STX-015-18-01 Sham control long-term safety follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long-Term Safety Follow-up | Drug | STX-015-18-01 long-term safety follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average and Worst NRS from Day 60 post injection to 12 months post injection | Difference in NRS pain scores from Day 60 of STX-015-18-01 to month 12 post injection | 10 months from completing Day 60 of the STX-015-18-01 study |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Surgeries | Difference in incidence of surgery, invasive treatment, and prescription medications due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01. | 12 months from day of injection |
| Incidence of Invasive treatment received |
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Inclusion Criteria:
Exclusion Criteria:
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Comprised of the first 100 subjects who completed all STX-015-18-01 study-related activities, age 18-70, male/female, reconfirmed eligible and signed informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Gilligan, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sollis Clinical Study Site 36 | Mobile | Alabama | 36605 | United States | ||
| Sollis Clinical Study Site 44 |
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Difference in incidence of invasive treatment due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01 |
| 12 months from day of injection |
| Number of Prescription medications taken | Difference in incidence of invasive treatment due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01 | 12 months from day of injection |
| Phoenix |
| Arizona |
| 85053 |
| United States |
| Sollis Clinical Study Site 40 | Tucson | Arizona | 85724 | United States |
| Sollis Clinical Study Site 49 | Rancho Mirage | California | 92270 | United States |
| Sollis Clinical Study Site 30 | Washington D.C. | District of Columbia | 22205 | United States |
| Sollis Clinical Study Site 35 | Fort Lauderdale | Florida | 33316 | United States |
| Sollis Clinical Study Site 38 | Miami | Florida | 33135 | United States |
| Sollis Clinical Study Site 12 | Bloomington | Illinois | 61704 | United States |
| Sollis Clinical Study Site 13 | Chicago | Illinois | 60657 | United States |
| Sollis Clinical Study Site 14 | Kansas City | Kansas | 66160 | United States |
| Sollis Clinical Study Site 37 | Overland Park | Kansas | 66210 | United States |
| Sollis Clinical Study Site 10 | Edgewood | Kentucky | 41017 | United States |
| Sollis Clinical Study Site 15 | Brookline | Massachusetts | 02445 | United States |
| Sollis Clinical Study Site 17 | Shrewsbury | New Jersey | 07702 | United States |
| Sollis Clinical Study Site 31 | Rochester | New York | 14618 | United States |
| Sollis Clinical Study Site 18 | Winston-Salem | North Carolina | 27103 | United States |
| Sollis Clinical Study Site 21 | Cleveland | Ohio | 44106 | United States |
| Sollis Clinical Study Site 33 | Cleveland | Ohio | 44195 | United States |
| Sollis Clinical Study Site 19 | Edmond | Oklahoma | 73013 | United States |
| Sollis Clinical Study Site 46 | Eugene | Oregon | 97401 | United States |
| Sollis Clinical Study Site 42 | Dallas | Texas | 75240 | United States |
| Sollis Clinical Study Site 34 | Houston | Texas | 77004 | United States |
| Sollis Clinical Study Site 47 | Salt Lake City | Utah | 84107 | United States |
| Sollis Clinical Study Site 23 | Morgantown | West Virginia | 26506 | United States |
| Sollis Clinical Study Site 27 | Madison | Wisconsin | 53792 | United States |