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NCT03776318 Clinical Trial

Long-Term Follow-up Safety of Clonidine Micropellets

Lumbosacral Radiculopathy Clinical Trial

— RePRIEVE-CM-LT  

Official title:
A Multicenter, Randomized, Follow-up Study to Evaluate the Long-Term Safety of Clonidine Micropellets for the Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03776318
Other study ID # STX-015-18-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 15, 2018
Est. completion date May 31, 2021

Study information
Verified date October 2023
Source Sollis Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months post injection.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date May 31, 2021
Est. primary completion date January 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Related Conditions & MeSH terms

Intervention

Drug:
• Long-Term Safety Follow-up
STX-015-18-01 long-term safety follow-up

Locations
Country Name City State
United States Sollis Clinical Study Site 12 Bloomington Illinois
United States Sollis Clinical Study Site 15 Brookline Massachusetts
United States Sollis Clinical Study Site 13 Chicago Illinois
United States Sollis Clinical Study Site 21 Cleveland Ohio
United States Sollis Clinical Study Site 33 Cleveland Ohio
United States Sollis Clinical Study Site 42 Dallas Texas
United States Sollis Clinical Study Site 10 Edgewood Kentucky
United States Sollis Clinical Study Site 19 Edmond Oklahoma
United States Sollis Clinical Study Site 46 Eugene Oregon
United States Sollis Clinical Study Site 35 Fort Lauderdale Florida
United States Sollis Clinical Study Site 34 Houston Texas
United States Sollis Clinical Study Site 14 Kansas City Kansas
United States Sollis Clinical Study Site 27 Madison Wisconsin
United States Sollis Clinical Study Site 38 Miami Florida
United States Sollis Clinical Study Site 36 Mobile Alabama
United States Sollis Clinical Study Site 23 Morgantown West Virginia
United States Sollis Clinical Study Site 37 Overland Park Kansas
United States Sollis Clinical Study Site 44 Phoenix Arizona
United States Sollis Clinical Study Site 49 Rancho Mirage California
United States Sollis Clinical Study Site 31 Rochester New York
United States Sollis Clinical Study Site 47 Salt Lake City Utah
United States Sollis Clinical Study Site 17 Shrewsbury New Jersey
United States Sollis Clinical Study Site 40 Tucson Arizona
United States Sollis Clinical Study Site 30 Washington District of Columbia
United States Sollis Clinical Study Site 18 Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Sollis Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Incidence of Invasive treatment received 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
Secondary 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
See also
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Terminated NCT05614648 - Sciatica Epidural Radiculopathy Experimental New Interventional TherapY Clonidine Micropellet Phase 3
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Terminated NCT03514277 - A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief Phase 4
Completed NCT01655849 - Phase 2 Efficacy Trial of Z160 in Lumbosacral Radiculopathy Phase 2
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Completed NCT00733096 - A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy Phase 2/Phase 3
Completed NCT01561027 - Crossover Study of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy Phase 2