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NCT Number: NCT03613662

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

This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of SP-102 administered by epidural injection.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Semnur Research Site 1

Boise, Idaho, 83713, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SP-102

Drug

Injection

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline

    Time frame: 12 weeks

    The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average leg pain scores over 24 hours are presented.

  2. Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline

    Time frame: 12 weeks

    The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average back pain scores over 24 hours are presented.

  3. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: 12 weeks

    Incidence of treatment-emergent AEs (TEAEs) related to study drug.

Sponsors and collaborators

Lead sponsor

Semnur Pharmaceuticals, Inc.

Industry

Collaborators

  • Scilex Pharmaceuticals, Inc.
  • Worldwide Clinical Trials

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 3, 2018
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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