A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102 (NCT03613662) | Clinical Trial Compass
CompletedPhase 2
A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102
United States19 participantsStarted 2018-07-13
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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.
What they're measuring
1
Change in Plasma Cortisol Concentrations From Baseline
Timeframe: 12 Weeks
2
Change in Blood Glucose Levels From Baseline
Timeframe: 12 Weeks
3
Change in White Blood Cell (WBC) Levels From Baseline