Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults (RePRIEVE-CM)

October 5, 2023 updated by: Sollis Therapeutics, Inc.

A Prospective, Multicenter, Randomized, Double-Blinded, Sham-Control Study to Evaluate the Efficacy and Safety of Clonidine Micropellets for the Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults

This study will evaluate the safety and effectiveness of a new pain medication in development, clonidine micropellet. Participants will receive a single injection of either clonidine micropellet or sham injection for the treatment of low back and leg pain from sciatica.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36605
        • Sollis Clinical Study Site 36
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Sollis Clinical Study Site #41
      • Phoenix, Arizona, United States, 85053
        • Sollis Clinical Study Site #44
      • Scottsdale, Arizona, United States, 85258
        • Sollis Clinical Study Site 29
      • Tucson, Arizona, United States, 85724
        • Sollis Clinical Study Site 40
    • California
      • Rancho Mirage, California, United States, 92270
        • Sollis Clinical Study Site 49
      • Santa Rosa, California, United States, 95401
        • Sollis Clinical Study Site 28
    • 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
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Sollis Clinical Study Site 10
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Sollis Clinical Study Site 16
      • Brookline, Massachusetts, United States, 02445
        • Sollis Clinical Study Site 15
    • New Jersey
      • Shrewsbury, New Jersey, United States, 60657
        • Sollis Clinical Study Site 17
    • New York
      • Albany, New York, United States, 12208
        • Sollis Clinical Study Site 25
      • Rochester, New York, United States, 14620
        • 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
      • Houston, Texas, United States, 77004
        • Sollis Clinical Study Site 34
      • San Antonio, Texas, United States, 78229
        • Sollis Clinical Study Site 22
      • The Woodlands, Texas, United States, 77382
        • Sollis Clinical Study Site 43
      • Tyler, Texas, United States, 75701
        • Sollis Clinical Study Site 20
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Sollis Clinical Study Site 47
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Sollis Clinical Study Site 23
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Sollis Clinical Study Site 27

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

  1. Be between 18 and 70 years of age (inclusive) at time the Informed Consent Form (ICF) is signed.
  2. Diagnosis of unilateral radicular leg pain.
  3. Women of childbearing potential must have a negative pregnancy test at Screening and within 24 hours prior to procedure and commit to adequate birth control during the the study.
  4. Understands the purpose and any risks associated with the procedure required for the study and is willing to participate in the study.
  5. Agrees to follow study-specific medication requirements.
  6. Be able to read, write, understand, and complete study-related tasks, and adequately communicate in English.
  7. Subject must have failed at least one conservative therapy in two different categories.

Main Exclusion Criteria:

  1. Medical condition or radiographic evidence that, in the Investigator's opinion, could adversely impact study outcomes.
  2. Received an lumbar epidural steroid injection, nerve block or similar procedure during the 4 weeks prior to Screening.
  3. Female subjects who are pregnant or breastfeeding.
  4. History of lumbar surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clonidine Micropellets
single dose injection into the lumbar epidural space
Combination product: Clonidine Micropellets
Injection
Sham Comparator: Sham Control
non-epidural needle placement
Other: Sham
Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D30 in radicular leg pain
Time Frame: Baseline to day 60
Difference in average pain score, using a scale of 0-10 with 0 no pain and 10 worst possible pain, from baseline to day 30.
Baseline to day 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oswestry Disability Index (ODI) score
Time Frame: Baseline to day 30
6 categories of 10 question, each question is scored from 0-5 (minimum to maximum). The scores range from 0-100% with lower scores meaning less disability.
Baseline to day 30
Change in Numeric Rating Scale (NRS) leg pain 24 hrs post injection.
Time Frame: 1 day post injection
Difference in average pain score, using a scale of 0-10 with 0 no pain and 10 worst possible pain, from injection to 24 hrs post injection.
1 day post injection
Difference in Rescue medication consumption
Time Frame: Baseline to day 30
Consumption from baseline through day 30
Baseline to day 30
Percent of subjects with significant improvement in pain
Time Frame: Baseline to day 30
50 percent improvement in pain from baseline to day 30
Baseline to day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sollis Therapeutics, Inc.

Collaborators

Lotus Clinical Research, LLC

Investigators

  • Principal Investigator: Christopher Gilligan, MD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Actual)

March 5, 2020

Study Completion (Actual)

July 18, 2020

Study Registration Dates

First Submitted

October 30, 2018

First Submitted That Met QC Criteria

October 31, 2018

First Posted (Actual)

November 1, 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

Other Study ID Numbers

  • STX-015-18-01

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

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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