Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

• 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: Scilex Pharmaceuticals, Inc.
• Collaborators: Worldwide Clinical Trials; Semnur Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Scilex Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: December 8, 2017
• First Posted Date: December 13, 2017
• Results First Submitted Date: August 19, 2022
• Results First Posted Date: September 19, 2022
• Last Update Posted Date: September 19, 2022
• Actual Study Start Date: December 8, 2017
• Actual Primary Completion Date: August 20, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: December 8, 2017): The mean change in leg pain scores [ Time Frame: Baseline to 4 Weeks ]

Current Secondary Outcome Measures (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 (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: Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Lumbosacral Radicular Pain

Intervention

• Drug: SP-102
  injection
• Drug: Placebo
  injection

Study Arms

• Experimental: SP-102
  SP-102
  Intervention: Drug: SP-102
• Placebo Comparator: Placebo
  Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 28, 2022): 401
• Original Estimated Enrollment (submitted: December 8, 2017): 400
• Actual Study Completion Date: January 6, 2022
• Actual Primary Completion Date: August 20, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03372161
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Scilex Pharmaceuticals, Inc.
• Original Responsible Party: Semnur Pharmaceuticals, Inc.
• Current Study Sponsor: Scilex Pharmaceuticals, Inc.
• Original Study Sponsor: Semnur Pharmaceuticals, Inc.

Collaborators

• Worldwide Clinical Trials
• Semnur Pharmaceuticals, Inc.

Investigators

• Study Director: Dmitri Lissin, MD; Scilex Pharmaceuticals, Inc.

• PRS Account: Scilex Pharmaceuticals, Inc.
• Verification Date: August 2022