Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults

NCT03727100 | Completed Phase 3 FDA Drug FDA Device

• 1 other identifier: STX-015-18-01
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 33

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.

Conditions

Lumbosacral Radiculopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Oswestry Disability Index (ODI) score

  Baseline to day 30

• Change in Numeric Rating Scale (NRS) leg pain 24 hrs post injection.

  1 day post injection

• Difference in Rescue medication consumption

  Baseline to day 30

• Percent of subjects with significant improvement in pain

  Baseline to day 30

Study Arms (2)

Clonidine Micropellets

ACTIVE COMPARATOR

single dose injection into the lumbar epidural space

Combination Product: Clonidine Micropellets

Sham Control

SHAM COMPARATOR

non-epidural needle placement

Other: Sham

Interventions

Clonidine Micropellets COMBINATION_PRODUCT

Injection

Clonidine Micropellets

Sham OTHER

Injection

Sham Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sollis Therapeutics, Inc.: lead
• Lotus Clinical Research, LLC: collaborator

Study Sites (33)

Sollis Clinical Study Site 36

Mobile, Alabama, 36605, United States

Location

Sollis Clinical Study Site #41

Phoenix, Arizona, 85018, United States

Location

Sollis Clinical Study Site #44

Phoenix, Arizona, 85053, United States

Location

Sollis Clinical Study Site 29

Scottsdale, Arizona, 85258, United States

Location

Sollis Clinical Study Site 40

Tucson, Arizona, 85724, United States

Location

Sollis Clinical Study Site 49

Rancho Mirage, California, 92270, United States

Location

Sollis Clinical Study Site 28

Santa Rosa, California, 95401, United States

Location

Sollis Clinical Study Site 30

Washington D.C., District of Columbia, 22205, United States

Location

Sollis Clinical Study Site 35

Fort Lauderdale, Florida, 33316, United States

Location

Sollis Clinical Study Site 38

Miami, Florida, 33135, United States

Location

Sollis Clinical Study Site 12

Bloomington, Illinois, 61704, United States

Location

Sollis Clinical Study Site 13

Chicago, Illinois, 60657, United States

Location

Sollis Clinical Study Site 14

Kansas City, Kansas, 66160, United States

Location

Sollis Clinical Study Site

Overland Park, Kansas, 66210, United States

Location

Sollis Clinical Study Site 10

Edgewood, Kentucky, 41017, United States

Location

Sollis Clinical Study Site 16

Boston, Massachusetts, 02115, United States

Location

Sollis Clinical Study Site 15

Brookline, Massachusetts, 02445, United States

Location

Sollis Clinical Study Site 17

Shrewsbury, New Jersey, 60657, United States

Location

Sollis Clinical Study Site 25

Albany, New York, 12208, United States

Location

Sollis Clinical Study Site 31

Rochester, New York, 14620, United States

Location

Sollis Clinical Study Site 18

Winston-Salem, North Carolina, 27103, United States

Location

Sollis Clinical Study Site 21

Cleveland, Ohio, 44106, United States

Location

Sollis Clinical Study Site 33

Cleveland, Ohio, 44195, United States

Location

Sollis Clinical Study Site 19

Edmond, Oklahoma, 73013, United States

Location

Sollis Clinical Study Site 46

Eugene, Oregon, 97401, United States

Location

Sollis Clinical Study Site

Dallas, Texas, 75240, United States

Location

Sollis Clinical Study Site 34

Houston, Texas, 77004, United States

Location

Sollis Clinical Study Site 22

San Antonio, Texas, 78229, United States

Location

Sollis Clinical Study Site 43

The Woodlands, Texas, 77382, United States

Location

Sollis Clinical Study Site 20

Tyler, Texas, 75701, United States

Location

Sollis Clinical Study Site 47

Salt Lake City, Utah, 84107, United States

Location

Sollis Clinical Study Site 23

Morgantown, West Virginia, 26505, United States

Location

Sollis Clinical Study Site 27

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

• Christopher Gilligan, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Clonidine Micropellet vs Sham-Control

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 1, 2018
• Study Start: October 16, 2018
• Primary Completion: March 5, 2020
• Study Completion: July 18, 2020
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (33)