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NCT Number: NCT03372161

Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

This is a research study of SP-102, an experimental medication designed to relieve pain in patients with a specific type of leg pain. The medication is given once by your healthcare professional, with a possibility of a second injection as early as about 1 month after the first treatment.

The purpose of the study is to measure how well a single injection of the experimental medication, SP-102, relieves pain. The study will also investigate the side effects of SP-102.

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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 3

Primary location

Semnur Research Site 75, Mobile, Alabama, United States

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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

Placebo

Drug

injection

Primary outcomes

  1. Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg

    Time frame: Baseline, 4 Weeks

    The NPRS is an 11-point scale (0 to 10-point scale where 0 was no pain and 10 was worst pain imaginable) that allowed the subject to rate the severity of their pain intensity at various points in time.

Secondary outcomes

  1. Mean Change From Baseline (Day 1) to Week 4 in the Oswestry Disability Index Score (ODI)

    Time frame: Baseline, 4 Weeks

    The ODI is the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. The ODI is a questionnaire completed by the subject that assesses10 topics: intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each question was scored on a scale of 0-5 with 0 indicating the least amount of disability and 5 indicating the most severe disability. The scores for all questions answered were summed, then multiplied by 2 to obtain the index (range 0 to 100). Zero was equated with no disability and 100 was the maximum disability possible.

Sponsors and collaborators

Lead sponsor

Scilex Pharmaceuticals, Inc.

Industry

Collaborators

  • Semnur Pharmaceuticals, Inc.
  • Worldwide Clinical Trials

Registry information

Official study title

Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Dec 13, 2017
Registry last updated
Sep 19, 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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