Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lumbosacral Radiculopathy

Intervention / Treatment
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* Combination Product: Clonidine Micropellets
* Other: Sham


Participation Criteria
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Eligibility Criteria
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Main 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. Main 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clonidine Micropellet vs Sham-Control
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clonidine Micropellets<br>single dose injection into the lumbar epidural space | Combination Product: Clonidine Micropellets<br>* Injection<br>|
| Sham Comparator: Sham Control<br>non-epidural needle placement | Other: Sham<br>* Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Difference in Rescue medication consumption | Consumption from baseline through day 30 | Baseline to day 30 | 
| Percent of subjects with significant improvement in pain | 50 percent improvement in pain from baseline to day 30 | Baseline to day 30 |