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Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03372161
Recruitment Status : Completed
First Posted : December 13, 2017
Results First Posted : September 19, 2022
Last Update Posted : September 19, 2022
Sponsor:
Collaborators:
Worldwide Clinical Trials
Semnur Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Scilex Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE December 8, 2017
First Posted Date  ICMJE December 13, 2017
Results First Submitted Date  ICMJE August 19, 2022
Results First Posted Date  ICMJE September 19, 2022
Last Update Posted Date September 19, 2022
Actual Study Start Date  ICMJE December 8, 2017
Actual Primary Completion Date August 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2022)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
The mean change in leg pain scores [ Time Frame: Baseline to 4 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2022)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
  • The change in disability index scores [ Time Frame: Baseline to 4 Weeks ]
  • The time to repeat injection of SP-102 [ Time Frame: Baseline to 4-20 Weeks ]
  • Patient Global Impression of Change [ Time Frame: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24 ]
  • Clinical Global Impression of Change [ Time Frame: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
Official Title  ICMJE Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lumbosacral Radicular Pain
Intervention  ICMJE
  • Drug: SP-102
    injection
  • Drug: Placebo
    injection
Study Arms  ICMJE
  • Experimental: SP-102
    SP-102
    Intervention: Drug: SP-102
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2022)
401
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2017)
400
Actual Study Completion Date  ICMJE January 6, 2022
Actual Primary Completion Date August 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03372161
Other Study ID Numbers  ICMJE SP-102-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Scilex Pharmaceuticals, Inc.
Original Responsible Party Semnur Pharmaceuticals, Inc.
Current Study Sponsor  ICMJE Scilex Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Semnur Pharmaceuticals, Inc.
Collaborators  ICMJE
  • Worldwide Clinical Trials
  • Semnur Pharmaceuticals, Inc.
Investigators  ICMJE
Study Director: Dmitri Lissin, MD Scilex Pharmaceuticals, Inc.
PRS Account Scilex Pharmaceuticals, Inc.
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP