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

Sollis Therapeutics, Inc.32 sites in 1 country207 target enrollmentOctober 16, 2018

ConditionsLumbosacral Radiculopathy

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Lumbosacral Radiculopathy
Sponsor: Sollis Therapeutics, Inc.
Enrollment: 207
Locations: 32
Primary Endpoint: Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D30 in radicular leg pain
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 16, 2018

End Date

July 18, 2020

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sollis Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

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.

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

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)
Percent of subjects with significant improvement in pain(Baseline to day 30)
Difference in Rescue medication consumption(Baseline to day 30)