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Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

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ClinicalTrials.gov Identifier: NCT03372161
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : February 20, 2018
Worldwide Clinical Trials
Information provided by (Responsible Party):
Semnur 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 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
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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 ClinicalTrials.gov identifier (NCT number): NCT03372161

Contact: Associate Director Clinical Operations 1-650-386-6709 clinicaltrials@semnurpharma.com

United States, California
Semnur Research Site 39 Recruiting
Campbell, California, United States, 95008
Semnur Research Site 37 Recruiting
Laguna Hills, California, United States, 92653
United States, Florida
Semnur Research Site 22 Recruiting
Orlando, Florida, United States, 32806
Semnur Research Site 13 Recruiting
Tampa, Florida, United States, 33603
Semnur Research Site 16 Recruiting
West Palm Beach, Florida, United States, 33409
United States, Georgia
Semnur Research Site 28 Recruiting
Marietta, Georgia, United States, 30060
Semnur Research Site 10 Recruiting
Newnan, Georgia, United States, 30265
United States, Idaho
Semnur Research Site 38 Recruiting
Boise, Idaho, United States, 83704
United States, Illinois
Semnur Research Site 40 Recruiting
Bloomington, Illinois, United States, 61704
Semnur Research Site 19 Recruiting
Chicago, Illinois, United States, 60657
United States, Missouri
Semnur Research Site 24 Recruiting
Saint Louis, Missouri, United States, 63141
United States, New Jersey
Semnur Research Site 30 Recruiting
Shrewsbury, New Jersey, United States, 07702
United States, North Carolina
Semnur Research Site 20 Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Texas
Semnur Research Site 15 Recruiting
Houston, Texas, United States, 77004
Semnur Research Site 35 Recruiting
Tyler, Texas, United States, 75701
United States, Utah
Semnur Research Site 41 Recruiting
Salt Lake City, Utah, United States, 84106
United States, Wisconsin
Semnur Research Site 42 Recruiting
Greenfield, Wisconsin, United States, 53220
Sponsors and Collaborators
Semnur Pharmaceuticals, Inc.
Worldwide Clinical Trials
Study Director: Dmitri Lissin, MD Semnur Pharmaceuticals, Inc.

Additional Information:
Responsible Party: Semnur Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03372161     History of Changes
Other Study ID Numbers: SP-102-02
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Semnur Pharmaceuticals, Inc.:
lumbosacral radicular pain
leg pain

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases