Long-Term Follow-up Safety of Clonidine Micropellets (RePRIEVE-CM-LT)

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

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

Study Overview

• Status: Completed
• Conditions: Lumbosacral Radiculopathy
• Intervention / Treatment: Drug: Long-Term Safety Follow-up

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36605
      • Sollis Clinical Study Site 36
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Sollis Clinical Study Site 44
    • Tucson, Arizona, United States, 85724
      • Sollis Clinical Study Site 40
  • California
    • Rancho Mirage, California, United States, 92270
      • Sollis Clinical Study Site 49
  • District of Columbia
    • Washington, District of Columbia, United States, 22205
      • Sollis Clinical Study Site 30
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • Sollis Clinical Study Site 35
    • Miami, Florida, United States, 33135
      • Sollis Clinical Study Site 38
  • Illinois
    • Bloomington, Illinois, United States, 61704
      • Sollis Clinical Study Site 12
    • Chicago, Illinois, United States, 60657
      • Sollis Clinical Study Site 13
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Sollis Clinical Study Site 14
    • Overland Park, Kansas, United States, 66210
      • Sollis Clinical Study Site 37
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Sollis Clinical Study Site 10
  • Massachusetts
    • Brookline, Massachusetts, United States, 02445
      • Sollis Clinical Study Site 15
  • New Jersey
    • Shrewsbury, New Jersey, United States, 07702
      • Sollis Clinical Study Site 17
  • New York
    • Rochester, New York, United States, 14618
      • Sollis Clinical Study Site 31
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Sollis Clinical Study Site 18
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Sollis Clinical Study Site 21
    • Cleveland, Ohio, United States, 44195
      • Sollis Clinical Study Site 33
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Sollis Clinical Study Site 19
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Sollis Clinical Study Site 46
  • Texas
    • Dallas, Texas, United States, 75240
      • Sollis Clinical Study Site 42
    • Houston, Texas, United States, 77004
      • Sollis Clinical Study Site 34
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Sollis Clinical Study Site 47
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Sollis Clinical Study Site 23
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Sollis Clinical Study Site 27

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Safety Group; STX-015-18-01 Clonidine Micropellet long-term safety follow-up	Drug: Long-Term Safety Follow-up; STX-015-18-01 long-term safety follow-up
Sham Control; STX-015-18-01 Sham control long-term safety follow-up	Drug: Long-Term Safety Follow-up; STX-015-18-01 long-term safety follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Sollis Therapeutics, Inc.
• Investigators: Principal Investigator: Christopher Gilligan, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Actual): January 22, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: December 1, 2018
• First Submitted That Met QC Criteria: December 12, 2018
• First Posted (Actual): December 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: STX-015-18-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No