Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

Study Overview
=================
Brief Summary
-----------------
This is a research study of SP-102, an experimental medication designed to relieve pain in patients with a specific type of leg pain. The medication is given once by your healthcare professional, with a possibility of a second injection as early as about 1 month after the first treatment. The purpose of the study is to measure how well a single injection of the experimental medication, SP-102, relieves pain. The study will also investigate the side effects of SP-102.

Official Title
-----------------
Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)

Conditions
-----------------
Lumbosacral Radicular Pain

Intervention / Treatment
-----------------
* Drug: SP-102
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Able and willing to read, write, and understand the English language and provide English language written informed consent prior to beginning any study procedures. Age 18 to 70 years (inclusive) at the Screening Visit. A diagnosis of lumbosacral radicular pain (sciatica). Agrees to follow study-specific medication requirements. If sexually active and a female of child-bearing potential or a male capable of bearing a child, agrees to use an effective method of birth control during the study. Has reviewed all study specific materials and has, in the opinion of the Investigator, the abilities to understand and appropriately complete all study procedures. Main Exclusion Criteria: Has radiologic evidence of a condition that would compromise study outcomes. Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while in the study. Has been diagnosed with insulin dependent diabetes mellitus. Presence of any other disorder, condition or circumstance (including secondary gain) that, in the opinion of the Investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments. Use of any investigational drug and/or device within 30 days, or is scheduled to receive an investigational drug other than blinded study drug during this study. Has a body mass index ≥40 kg/m2.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SP-102<br>SP-102 | Drug: SP-102<br>* injection<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg | The NPRS is an 11-point scale (0 to 10-point scale where 0 was no pain and 10 was worst pain imaginable) that allowed the subject to rate the severity of their pain intensity at various points in time. | Baseline, 4 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline (Day 1) to Week 4 in the Oswestry Disability Index Score (ODI) | The ODI is the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. The ODI is a questionnaire completed by the subject that assesses10 topics: intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each question was scored on a scale of 0-5 with 0 indicating the least amount of disability and 5 indicating the most severe disability. The scores for all questions answered were summed, then multiplied by 2 to obtain the index (range 0 to 100). Zero was equated with no disability and 100 was the maximum disability possible. | Baseline, 4 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lumbosacral radicular pain, sciatica, leg pain