Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults

Phase 3

Completed

• Conditions: Lumbosacral Radiculopathy

• Registration Number: NCT03727100
• Lead Sponsor: Sollis Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-16
• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-01
• Primary Completion: 2020-03-05
• Study Completion: 2020-07-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (32)

Sollis Clinical Study Site 36; 🇺🇸 Mobile, Alabama, United States

Sollis Clinical Study Site #41; 🇺🇸 Phoenix, Arizona, United States

Sollis Clinical Study Site #44; 🇺🇸 Phoenix, Arizona, United States

Sollis Clinical Study Site 29; 🇺🇸 Scottsdale, Arizona, United States

Sollis Clinical Study Site 40; 🇺🇸 Tucson, Arizona, United States

Sollis Clinical Study Site 49; 🇺🇸 Rancho Mirage, California, United States

Sollis Clinical Study Site 28; 🇺🇸 Santa Rosa, California, United States

Sollis Clinical Study Site 30; 🇺🇸 Washington, District of Columbia, United States

Sollis Clinical Study Site 35; 🇺🇸 Fort Lauderdale, Florida, United States

Sollis Clinical Study Site 38; 🇺🇸 Miami, Florida, United States

Scroll for more (22 remaining)