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Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults

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

NCT03727100•Sollis Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.

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.

Locations (33)

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 D.C., District of Columbia, United States

Sollis Clinical Study Site 35

Fort Lauderdale, Florida, United States

Sollis Clinical Study Site 38

Miami, Florida, United States

Key Dates

Start Date

October 16, 2018

Primary Completion Date

March 5, 2020

Completion Date

July 18, 2020

Last Updated

October 6, 2023

Enrollment

207

ACTUAL participants

Conditions

Lumbosacral Radiculopathy

Interventions

Clonidine Micropellets

COMBINATION_PRODUCT

Sham

OTHER

Augmented Posterior Oblique Sling Activation on Lumbopelvic Recruitment Pattern in Lumbosacral Radiculopathy

NCT06558383

Lumbosacral Radiculopathy

View study

COMPLETEDPHASE2

Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR)

NCT06176196

Painful Lumbosacral Radiculopathy

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NOT_YET_RECRUITINGNA

Effect of Kinetic Control in Lumbosacral Radiculopathy.

NCT07079202

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults

Inclusion Criteria

Exclusion Criteria

Augmented Posterior Oblique Sling Activation on Lumbopelvic Recruitment Pattern in Lumbosacral Radiculopathy

Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR)

Effect of Kinetic Control in Lumbosacral Radiculopathy.

Long-Term Follow-up Safety of Clonidine Micropellets

Effects of Multimodal Physical Therapy in Patients With Lumbosacral Radiculopathy

Effects of Mackenzie Extension and William Flexion Exercises in Lumbo-sarcal Radiculopathy