Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

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

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.

Study Overview

• Status: Completed
• Conditions: Lumbosacral Radicular Pain
• Intervention / Treatment: Drug: SP-102; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 401
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36605
      • Semnur Research Site 75
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Semnur Research Site 52
    • Tempe, Arizona, United States, 85284
      • Semnur Research Site 58
  • California
    • La Jolla, California, United States, 92037
      • Semnur Research Site 18
    • Laguna Woods, California, United States, 92637
      • Semnur Research Site 47
    • Los Gatos, California, United States, 95032
      • Semnur Research Site 70
  • Florida
    • Fernandina Beach, Florida, United States, 32024
      • Semnur Research Site 56
    • Jacksonville, Florida, United States, 32224
      • Semnur Research Site 81
    • Saint Petersburg, Florida, United States, 33709
      • Semnur Research Site 49
    • Tampa, Florida, United States, 33603
      • Semnur Research Site 13
    • Tampa, Florida, United States, 33603
      • Semnur Research Site 61
    • Winter Park, Florida, United States, 32789
      • Semnur Research Site 53
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Semnur Research Site 28
    • Marietta, Georgia, United States, 30060
      • Semnur Research Site 64
    • Newnan, Georgia, United States, 30265
      • Semnur Research Site 10
  • Idaho
    • Boise, Idaho, United States, 83704
      • Semnur Research Site 38
  • Illinois
    • Bloomington, Illinois, United States, 61704
      • Semnur Research Site 40
    • Chicago, Illinois, United States, 60607
      • Semnur Research Site 63
    • Chicago, Illinois, United States, 60612
      • Semnur Research Site 12
    • Chicago, Illinois, United States, 60657
      • Semnur Research Site 19
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Semnur Reseach Site 62
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Semnur Research Site 51
  • Nebraska
    • Omaha, Nebraska, United States, 68118
      • Semnur Research Site 65
  • Nevada
    • Las Vegas, Nevada, United States, 89129
      • Semnur Research Site 60
  • New Jersey
    • Shrewsbury, New Jersey, United States, 07702
      • Semnur Research Site 30
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Semnur Research Site 11
    • Winston-Salem, North Carolina, United States, 27103
      • Semnur Research Site 20
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Semnur Research Site 46
    • Cuyahoga Falls, Ohio, United States, 44223
      • Semnur Research Site 43
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • Semnur Research Site 36
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Semnur Research Site 48
    • Greenville, South Carolina, United States, 29615
      • Semnur Research Site 77
  • Texas
    • Houston, Texas, United States, 77004
      • Semnur Research Site 15
    • Plano, Texas, United States, 75093
      • Semnur Research Site 54
    • Tyler, Texas, United States, 75701
      • Semnur Research Site 35
  • Utah
    • Draper, Utah, United States, 84020
      • Semnur Research Site 59
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53220
      • Semnur Research Site 42

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; injection
EXPERIMENTAL: SP-102	Drug: SP-102; injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg	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.	Baseline, 4 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline (Day 1) to Week 4 in the Oswestry Disability Index Score (ODI)	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.	Baseline, 4 Weeks

Collaborators and Investigators

• Sponsor: Scilex Pharmaceuticals, Inc.
• Collaborators: Worldwide Clinical Trials; Semnur Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 8, 2017
• Primary Completion (ACTUAL): August 20, 2021
• Study Completion (ACTUAL): January 6, 2022

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (ACTUAL): December 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: leg pain; lumbosacral radicular pain; sciatica
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: SP-102-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No