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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03372161
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
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

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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 : January 1, 2020
Estimated Study Completion Date : June 1, 2020

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

Placebo Comparator: Placebo
Placebo
Drug: Placebo
injection




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, 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.

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


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

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Locations
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United States, Alabama
Semnur Research Site 57 Recruiting
Birmingham, Alabama, United States, 35235
United States, Arizona
Semnur Research Site 52 Recruiting
Phoenix, Arizona, United States, 85053
Semnur Research Site 58 Recruiting
Tempe, Arizona, United States, 85284
United States, California
Semnur Research Site 39 Withdrawn
Campbell, California, United States, 95008
Semnur Research Site 18 Recruiting
La Jolla, California, United States, 92037
Semnur Research Site 37 Withdrawn
Laguna Hills, California, United States, 92653
Semnur Research Site 47 Recruiting
Laguna Woods, California, United States, 92637
Semnur Research Site 70 Recruiting
Los Gatos, California, United States, 95032
Semnur Research Site 66 Recruiting
Santa Monica, California, United States, 90404
Semnur Research Site 44 Withdrawn
Stanford, California, United States, 94305
United States, Colorado
Semnur Research Site 55 Recruiting
Aurora, Colorado, United States, 80012
Semnur Research Site 14 Withdrawn
Greenwood Village, Colorado, United States, 80111
United States, Florida
Semnur Research Site 56 Recruiting
Fernandina Beach, Florida, United States, 32024
Semnur Research Site 22 Withdrawn
Orlando, Florida, United States, 32806
Semnur Research Site 49 Recruiting
Saint Petersburg, Florida, United States, 33709
Semnur Reserach Site 69 Recruiting
Tallahassee, Florida, United States, 32308
Semnur Research Site 13 Recruiting
Tampa, Florida, United States, 33603
Semnur Research Site 61 Recruiting
Tampa, Florida, United States, 33603
Semnur Research Site 16 Withdrawn
West Palm Beach, Florida, United States, 33409
Semnur Research Site 53 Recruiting
Winter Park, Florida, United States, 32789
United States, Georgia
Semnur Research Site 28 Recruiting
Marietta, Georgia, United States, 30060
Semnur Research Site 64 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 63 Recruiting
Chicago, Illinois, United States, 60607
Semnur Research Site 12 Recruiting
Chicago, Illinois, United States, 60612
Semnur Research Site 19 Recruiting
Chicago, Illinois, United States, 60657
United States, Kansas
Semnur Reseach Site 62 Recruiting
Overland Park, Kansas, United States, 66210
United States, Massachusetts
Semnur Research Site 51 Recruiting
Burlington, Massachusetts, United States, 01805
United States, Michigan
Semnur Research Site 67 Recruiting
Wyoming, Michigan, United States, 41519
United States, Missouri
Semnur Research Site 24 Recruiting
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Semnur Research Site 65 Recruiting
Omaha, Nebraska, United States, 68118
United States, Nevada
Semnur Research Site 60 Recruiting
Las Vegas, Nevada, United States, 89129
United States, New Jersey
Semnur Research Site 30 Recruiting
Shrewsbury, New Jersey, United States, 07702
United States, New York
Semnur Research Site 50 Withdrawn
New York, New York, United States, 10022
Semnur Research Site 23 Recruiting
Rochester, New York, United States, 14618
United States, North Carolina
Semnur Research Site 11 Recruiting
Durham, North Carolina, United States, 27710
Semnur Research Site 20 Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Semnur Research Site 46 Recruiting
Cleveland, Ohio, United States, 44106
Semnur Research Site 43 Recruiting
Cuyahoga Falls, Ohio, United States, 44223
United States, Oklahoma
Semnur Research Site 36 Recruiting
Oklahoma City, Oklahoma, United States, 73109
United States, South Carolina
Semnur Research Site 48 Recruiting
Charleston, South Carolina, United States, 29406
United States, Tennessee
Semnur Research Site 33 Withdrawn
Nashville, Tennessee, United States, 37212
United States, Texas
Semnur Research Site 68 Recruiting
Dallas, Texas, United States, 75240
Semnur Research Site 15 Recruiting
Houston, Texas, United States, 77004
Semnur Research Site 54 Recruiting
Plano, Texas, United States, 75093
Semnur Research Site 35 Recruiting
Tyler, Texas, United States, 75701
United States, Utah
Semnur Research Site 59 Recruiting
Draper, Utah, United States, 84020
Semnur Research Site 41 Withdrawn
Salt Lake City, Utah, United States, 84106
United States, Wisconsin
Semnur Research Site 42 Completed
Greenfield, Wisconsin, United States, 53220
Sponsors and Collaborators
Semnur Pharmaceuticals, Inc.
Worldwide Clinical Trials
Investigators
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Study Director: Dmitri Lissin, MD Semnur Pharmaceuticals, Inc.

Additional Information:
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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: July 4, 2019
Last Verified: July 2019

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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 Semnur 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