A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102

Study Overview
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Brief Summary
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This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of SP-102 administered by epidural injection.

Official Title
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An Open-label, Single-arm Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102 Administered by Epidural Injection in Subjects With Lumbosacral Radiculopathy

Conditions
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Lumbosacral Radicular Pain

Intervention / Treatment
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* Drug: SP-102


Participation Criteria
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Eligibility Criteria
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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
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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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Plasma Cortisol Concentrations From Baseline | Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in plasma cortisol levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks | 12 Weeks | 
| Change in Blood Glucose Levels From Baseline | Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in blood glucose levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks | 12 Weeks | 
| Change in White Blood Cell (WBC) Levels From Baseline | Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in WBC levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline | The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average leg pain scores over 24 hours are presented. | 12 weeks | 
| Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline | The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average back pain scores over 24 hours are presented. | 12 weeks | 
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Incidence of treatment-emergent AEs (TEAEs) related to study drug. | 12 weeks | 

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