Long-Term Follow-up Safety of Clonidine Micropellets
- Conditions
- Lumbosacral Radiculopathy
- Interventions
- Drug: Long-Term Safety Follow-up
- Registration Number
- NCT03776318
- Lead Sponsor
- Sollis Therapeutics, Inc.
- Brief Summary
Long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months post injection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Subject who have successfully completed all STX-015-18-01 study related activities, are reconfirmed to be eligible and have signed informed consent to participate.
- Subjects who, in the opinion of the investigator, have demonstrated significant non-compliance with STX-015-18-01 study procedures.
- Subjects who were unblinded to their treatment in STX-015-18-01 study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sham Control Long-Term Safety Follow-up STX-015-18-01 Sham control long-term safety follow-up Safety Group Long-Term Safety Follow-up STX-015-18-01 Clonidine Micropellet long-term safety follow-up
- Primary Outcome Measures
Name Time Method Change in Average and Worst NRS from Day 60 post injection to 12 months post injection 10 months from completing Day 60 of the STX-015-18-01 study Difference in NRS pain scores from Day 60 of STX-015-18-01 to month 12 post injection
- Secondary Outcome Measures
Name Time Method Incidence of Surgeries 12 months from day of injection 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.
Incidence of Invasive treatment received 12 months from day of injection 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
Number of Prescription medications taken 12 months from day of injection 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
Trial Locations
- Locations (25)
Sollis Clinical Study Site 35
🇺🇸Fort Lauderdale, Florida, United States
Sollis Clinical Study Site 23
🇺🇸Morgantown, West Virginia, United States
Sollis Clinical Study Site 33
🇺🇸Cleveland, Ohio, United States
Sollis Clinical Study Site 34
🇺🇸Houston, Texas, United States
Sollis Clinical Study Site 13
🇺🇸Chicago, Illinois, United States
Sollis Clinical Study Site 38
🇺🇸Miami, Florida, United States
Sollis Clinical Study Site 49
🇺🇸Rancho Mirage, California, United States
Sollis Clinical Study Site 21
🇺🇸Cleveland, Ohio, United States
Sollis Clinical Study Site 15
🇺🇸Brookline, Massachusetts, United States
Sollis Clinical Study Site 37
🇺🇸Overland Park, Kansas, United States
Sollis Clinical Study Site 27
🇺🇸Madison, Wisconsin, United States
Sollis Clinical Study Site 12
🇺🇸Bloomington, Illinois, United States
Sollis Clinical Study Site 14
🇺🇸Kansas City, Kansas, United States
Sollis Clinical Study Site 17
🇺🇸Shrewsbury, New Jersey, United States
Sollis Clinical Study Site 46
🇺🇸Eugene, Oregon, United States
Sollis Clinical Study Site 40
🇺🇸Tucson, Arizona, United States
Sollis Clinical Study Site 47
🇺🇸Salt Lake City, Utah, United States
Sollis Clinical Study Site 44
🇺🇸Phoenix, Arizona, United States
Sollis Clinical Study Site 30
🇺🇸Washington, District of Columbia, United States
Sollis Clinical Study Site 10
🇺🇸Edgewood, Kentucky, United States
Sollis Clinical Study Site 31
🇺🇸Rochester, New York, United States
Sollis Clinical Study Site 19
🇺🇸Edmond, Oklahoma, United States
Sollis Clinical Study Site 42
🇺🇸Dallas, Texas, United States
Sollis Clinical Study Site 36
🇺🇸Mobile, Alabama, United States
Sollis Clinical Study Site 18
🇺🇸Winston-Salem, North Carolina, United States