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 1, 2021
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Sponsor:
Semnur Pharmaceuticals, Inc.
Collaborators:
Worldwide Clinical Trials
Scilex Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Scilex Pharmaceuticals, Inc. ( Semnur Pharmaceuticals, Inc. )
Tracking Information | |||||
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First Submitted Date ICMJE | December 8, 2017 | ||||
First Posted Date ICMJE | December 13, 2017 | ||||
Last Update Posted Date | February 1, 2021 | ||||
Actual Study Start Date ICMJE | December 8, 2017 | ||||
Estimated Primary Completion Date | January 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||
Original Primary Outcome Measures ICMJE |
The mean change in leg pain scores [ Time Frame: Baseline to 4 Weeks ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Corticosteroid Lumbar Epidural Analgesia for Radiculopathy | ||||
Official Title ICMJE | 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 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. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Lumbosacral Radicular Pain | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
400 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 2021 | ||||
Estimated Primary Completion Date | January 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Main Inclusion Criteria:
Main Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03372161 | ||||
Other Study ID Numbers ICMJE | SP-102-02 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Scilex Pharmaceuticals, Inc. ( Semnur Pharmaceuticals, Inc. ) | ||||
Study Sponsor ICMJE | Semnur Pharmaceuticals, Inc. | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Scilex Pharmaceuticals, Inc. | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |