Clinical trial NCT03613662: A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lumbosacral Radicular Pain
Keywords: lumbosacral radicular pain
sciatica
leg pain
Lead sponsor: Scilex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Worldwide Clinical Trials
name: Scilex Pharmaceuticals, Inc.
First posted: 2018-08-03
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Plasma Cortisol Concentrations From Baseline
timeFrame: 12 Weeks
measure: Change in Blood Glucose Levels From Baseline
timeFrame: 12 Weeks
measure: Change in White Blood Cell (WBC) Levels From Baseline
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
timeFrame: 12 weeks
measure: Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
timeFrame: 12 weeks
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boise
country: United States
facility: Semnur Research Site 1
state: Idaho
Study officials:
affiliation: Scilex Pharmaceuticals, Inc.
name: Dmitri Lissin, MD
role: STUDY_DIRECTOR
References:
citation: Radnovich R, Heinz J, Ambrose C, Stannard E, Lissin D. Repeat Epidural Injections of SP-102 (Dexamethasone Sodium Phosphate Injectable Gel) in Subjects with Lumbosacral Radiculopathy. J Pain Res. 2021 May 5;14:1231-1239. doi: 10.2147/JPR.S303282. eCollection 2021.