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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in Plasma Cortisol Concentrations From Baseline
研究概览
简要总结
This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of SP-102 administered by epidural injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
SP-102
SP-102
干预措施: SP-102 (Drug)
结局指标
主要结局
Change in Plasma Cortisol Concentrations From Baseline
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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)