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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. Identifier: NCT03372161
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : January 31, 2022
Worldwide Clinical Trials
Semnur Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Scilex Pharmaceuticals, Inc.

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 mediation 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

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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

Arm Intervention/treatment
Experimental: SP-102
Drug: SP-102

Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. The mean change in leg pain scores using the Numerical Pain Rating Scale (0-10, 0 is no pain, 10 is worst pain imaginable) [ Time Frame: Baseline to 4 Weeks ]

Secondary Outcome Measures :
  1. The change in the Oswestry Disability Index score (0-100, 0 is with no disability, 100 is the maximum disability) [ Time Frame: Baseline to 4 Weeks ]
  2. The time to repeat injection of SP-102 [ Time Frame: Baseline to 4-20 Weeks ]
  3. Patient Global Impression of Change [ Time Frame: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24 ]
  4. Clinical Global Impression of Change [ Time Frame: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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.

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 identifier (NCT number): NCT03372161

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Sponsors and Collaborators
Scilex Pharmaceuticals, Inc.
Worldwide Clinical Trials
Semnur Pharmaceuticals, Inc.
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Study Director: Dmitri Lissin, MD Scilex Pharmaceuticals, Inc.
Additional Information:
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Responsible Party: Scilex Pharmaceuticals, Inc. Identifier: NCT03372161    
Other Study ID Numbers: SP-102-02
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: January 31, 2022
Last Verified: January 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
leg pain
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases