Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults

Lumbosacral Radiculopathy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727100
• Other study ID #: STX-015-18-01
• Status: Completed
• Phase: Phase 3
• Start date: October 16, 2018
• Est. completion date: July 18, 2020

Study information

• Verified date: October 2023
• Source: Sollis Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: July 18, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lumbosacral Radiculopathy
• Radiculopathy

Intervention

Combination Product:
• Clonidine Micropellets
Injection

Other:
• Sham
Injection

Locations

Country	Name	City	State
United States	Sollis Clinical Study Site 25	Albany	New York
United States	Sollis Clinical Study Site 12	Bloomington	Illinois
United States	Sollis Clinical Study Site 16	Boston	Massachusetts
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	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	Overland Park	Kansas
United States	Sollis Clinical Study Site #41	Phoenix	Arizona
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 22	San Antonio	Texas
United States	Sollis Clinical Study Site 28	Santa Rosa	California
United States	Sollis Clinical Study Site 29	Scottsdale	Arizona
United States	Sollis Clinical Study Site 17	Shrewsbury	New Jersey
United States	Sollis Clinical Study Site 43	The Woodlands	Texas
United States	Sollis Clinical Study Site 40	Tucson	Arizona
United States	Sollis Clinical Study Site 20	Tyler	Texas
United States	Sollis Clinical Study Site 30	Washington	District of Columbia
United States	Sollis Clinical Study Site 18	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Sollis Therapeutics, Inc.	Lotus Clinical Research, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to day 60
Secondary	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.	Baseline to day 30
Secondary	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.	1 day post injection
Secondary	Difference in Rescue medication consumption	Consumption from baseline through day 30	Baseline to day 30
Secondary	Percent of subjects with significant improvement in pain	50 percent improvement in pain from baseline to day 30	Baseline to day 30