A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102

NCT03613662 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SP-102-03
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbosacral Radicular Pain

Keywords

lumbosacral radicular pain; sciatica; leg pain

Outcome Measures

Primary Outcomes (3)

• Change in Plasma Cortisol Concentrations From Baseline

  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

  12 Weeks

• Change in Blood Glucose Levels From Baseline

  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

  12 Weeks

• Change in White Blood Cell (WBC) Levels From Baseline

  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

  12 Weeks

Secondary Outcomes (3)

• 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

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  12 weeks

Study Arms (1)

SP-102

EXPERIMENTAL

SP-102

Drug: SP-102

Interventions

SP-102 DRUG

Injection

SP-102

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Semnur Pharmaceuticals, Inc.: lead
• Worldwide Clinical Trials: collaborator
• Scilex Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Semnur Research Site 1

Boise, Idaho, 83713, United States

Location

Related Publications (1)

• 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.

  PMID: 33981160 RESULT

MeSH Terms

Conditions

Sciatica

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Associate Director Clinical Operations
• Organization: Scilex Pharmaceuticals, Inc.

cambrose@scilexpharma.com

6503866709

Study Officials

• Dmitri Lissin, MD

  Scilex Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 3, 2018
• Study Start: July 13, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: January 13, 2022
• Results First Posted: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)