Phase 2
Completed N=19
A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102
Lumbosacral Radicular Pain
Source: ClinicalTrials.gov NCT03613662 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: Change in Plasma Cortisol Concentrations From Baseline — 36.62; 0.64; 6.26; 29.77 nmol/L
Summary
This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of SP-102 administered by epidural injection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Plasma Cortisol Concentrations From Baseline |
36.62; 0.64; 6.26; 29.77; 39.91; 39.71 | — |
| PRIMARY Change in Blood Glucose Levels From Baseline |
4.993; 6.155; 4.528; 4.676; 4.958; 5.059 | — |
| PRIMARY Change in White Blood Cell (WBC) Levels From Baseline |
6.65; 13.43; 9.33; 7.38; 6.81; 6.91 | — |
| SECONDARY Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline |
5.4; 5.3; 3.2; 2.2; 2.5; 2.3 | — |
| SECONDARY Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline |
5.2; 5.2; 3.5; 2.3; 2.7; 2.6 | — |
| SECONDARY Incidence of Treatment-Emergent Adverse Events (TEAEs) |
20; 10 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03613662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.