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
Overview
- Phase
- Phase 2
- Intervention
- SP-102
- Conditions
- Lumbosacral Radicular Pain
- Sponsor
- Semnur Pharmaceuticals, Inc.
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Change in Plasma Cortisol Concentrations From Baseline
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
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.
Arms & Interventions
SP-102
SP-102
Intervention: SP-102
Outcomes
Primary Outcomes
Change in Plasma Cortisol Concentrations From Baseline
Time Frame: 12 Weeks
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
Change in Blood Glucose Levels From Baseline
Time Frame: 12 Weeks
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
Change in White Blood Cell (WBC) Levels From Baseline
Time Frame: 12 Weeks
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
Secondary Outcomes
- Incidence of Treatment-Emergent Adverse Events (TEAEs)(12 weeks)
- Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline(12 weeks)
- Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline(12 weeks)