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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.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lumbosacral Radicular Pain Drug: SP-102 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)
Actual Study Start Date : December 8, 2017
Actual Primary Completion Date : August 20, 2021
Actual Study Completion Date : January 6, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: SP-102
SP-102
 Drug: SP-102
injection
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
injection


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372161


Locations
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Sponsors and Collaborators
Scilex Pharmaceuticals, Inc.
Worldwide Clinical Trials
Semnur Pharmaceuticals, Inc.
Investigators
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Study Director: Dmitri Lissin, MD Scilex Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Scilex Pharmaceuticals, Inc.:
Study Protocol  [PDF] May 24, 2018
Statistical Analysis Plan  [PDF] August 20, 2021

More Information
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Responsible Party: Scilex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03372161    
Other Study ID Numbers: SP-102-02
First Posted: December 13, 2017    Key Record Dates
Results First Posted: September 19, 2022
Last Update Posted: September 19, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scilex Pharmaceuticals, Inc.:
lumbosacral radicular pain
sciatica
leg pain
Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases