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

Primary Purpose

Lumbosacral Radiculopathy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Clonidine Micropellets
Sham
Sponsored by
Sollis Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbosacral Radiculopathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sollis Clinical Study Site 36
  • Sollis Clinical Study Site #41
  • Sollis Clinical Study Site #44
  • Sollis Clinical Study Site 29
  • Sollis Clinical Study Site 40
  • Sollis Clinical Study Site 49
  • Sollis Clinical Study Site 28
  • Sollis Clinical Study Site 30
  • Sollis Clinical Study Site 35
  • Sollis Clinical Study Site 38
  • Sollis Clinical Study Site 12
  • Sollis Clinical Study Site 13
  • Sollis Clinical Study Site 14
  • Sollis Clinical Study Site
  • Sollis Clinical Study Site 10
  • Sollis Clinical Study Site 16
  • Sollis Clinical Study Site 15
  • Sollis Clinical Study Site 17
  • Sollis Clinical Study Site 25
  • Sollis Clinical Study Site 31
  • Sollis Clinical Study Site 18
  • Sollis Clinical Study Site 21
  • Sollis Clinical Study Site 33
  • Sollis Clinical Study Site 19
  • Sollis Clinical Study Site 46
  • Sollis Clinical Study Site
  • Sollis Clinical Study Site 34
  • Sollis Clinical Study Site 22
  • Sollis Clinical Study Site 43
  • Sollis Clinical Study Site 20
  • Sollis Clinical Study Site 47
  • Sollis Clinical Study Site 23
  • Sollis Clinical Study Site 27

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Clonidine Micropellets

Sham Control

Arm Description

single dose injection into the lumbar epidural space

non-epidural needle placement

Outcomes

Primary Outcome Measures

Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D30 in radicular leg pain
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.

Secondary Outcome Measures

Change in Oswestry Disability Index (ODI) score
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.
Change in Numeric Rating Scale (NRS) leg pain 24 hrs 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.
Difference in Rescue medication consumption
Consumption from baseline through day 30
Percent of subjects with significant improvement in pain
50 percent improvement in pain from baseline to day 30

Full Information

First Posted
October 30, 2018
Last Updated
October 5, 2023
Sponsor
Sollis Therapeutics, Inc.
Collaborators
Lotus Clinical Research, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03727100
Brief Title
Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults
Acronym
RePRIEVE-CM
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
July 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sollis Therapeutics, Inc.
Collaborators
Lotus Clinical Research, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbosacral Radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Clonidine Micropellet vs Sham-Control
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double-Blinded
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clonidine Micropellets
Arm Type
Active Comparator
Arm Description
single dose injection into the lumbar epidural space
Arm Title
Sham Control
Arm Type
Sham Comparator
Arm Description
non-epidural needle placement
Intervention Type
Combination Product
Intervention Name(s)
Clonidine Micropellets
Intervention Description
Injection
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Injection
Primary Outcome Measure Information:
Title
Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D30 in radicular leg pain
Description
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.
Time Frame
Baseline to day 60
Secondary Outcome Measure Information:
Title
Change in Oswestry Disability Index (ODI) score
Description
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.
Time Frame
Baseline to day 30
Title
Change in Numeric Rating Scale (NRS) leg pain 24 hrs post injection.
Description
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.
Time Frame
1 day post injection
Title
Difference in Rescue medication consumption
Description
Consumption from baseline through day 30
Time Frame
Baseline to day 30
Title
Percent of subjects with significant improvement in pain
Description
50 percent improvement in pain from baseline to day 30
Time Frame
Baseline to day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Be between 18 and 70 years of age (inclusive) at time the Informed Consent Form (ICF) is signed. Diagnosis of unilateral radicular leg pain. 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. Understands the purpose and any risks associated with the procedure required for the study and is willing to participate in the study. Agrees to follow study-specific medication requirements. Be able to read, write, understand, and complete study-related tasks, and adequately communicate in English. Subject must have failed at least one conservative therapy in two different categories. Main Exclusion Criteria: Medical condition or radiographic evidence that, in the Investigator's opinion, could adversely impact study outcomes. Received an lumbar epidural steroid injection, nerve block or similar procedure during the 4 weeks prior to Screening. Female subjects who are pregnant or breastfeeding. History of lumbar surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Gilligan, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sollis Clinical Study Site 36
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36605
Country
United States
Facility Name
Sollis Clinical Study Site #41
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Sollis Clinical Study Site #44
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Sollis Clinical Study Site 29
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Sollis Clinical Study Site 40
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Sollis Clinical Study Site 49
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Sollis Clinical Study Site 28
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95401
Country
United States
Facility Name
Sollis Clinical Study Site 30
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
22205
Country
United States
Facility Name
Sollis Clinical Study Site 35
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Sollis Clinical Study Site 38
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Sollis Clinical Study Site 12
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Sollis Clinical Study Site 13
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Sollis Clinical Study Site 14
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Sollis Clinical Study Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Sollis Clinical Study Site 10
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Sollis Clinical Study Site 16
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Sollis Clinical Study Site 15
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Facility Name
Sollis Clinical Study Site 17
City
Shrewsbury
State/Province
New Jersey
ZIP/Postal Code
60657
Country
United States
Facility Name
Sollis Clinical Study Site 25
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Sollis Clinical Study Site 31
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Sollis Clinical Study Site 18
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Sollis Clinical Study Site 21
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Sollis Clinical Study Site 33
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Sollis Clinical Study Site 19
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Sollis Clinical Study Site 46
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Sollis Clinical Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75240
Country
United States
Facility Name
Sollis Clinical Study Site 34
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Sollis Clinical Study Site 22
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sollis Clinical Study Site 43
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77382
Country
United States
Facility Name
Sollis Clinical Study Site 20
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Sollis Clinical Study Site 47
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Sollis Clinical Study Site 23
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Sollis Clinical Study Site 27
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults

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