Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
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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 |
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Recruitment Status :
Recruiting
First Posted : December 13, 2017
Last Update Posted : May 21, 2020
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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. )
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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 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 1, 2020 |
| Estimated Study Completion Date : | December 1, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: SP-102
SP-102
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Drug: SP-102
injection |
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Placebo Comparator: Placebo
Placebo
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Drug: Placebo
injection |
Primary Outcome Measures :
- 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 :
- 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 ]
- The time to repeat injection of SP-102 [ Time Frame: Baseline to 4-20 Weeks ]
- Patient Global Impression of Change [ Time Frame: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24 ]
- Clinical Global Impression of Change [ Time Frame: Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24 ]
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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
| Contact: Associate Director Clinical Operations | 1-650-386-6709 | cambrose@scilexpharma.com |
Locations
Show 57 study locations
Sponsors and Collaborators
Semnur Pharmaceuticals, Inc.
Worldwide Clinical Trials
Scilex Pharmaceuticals, Inc.
Investigators
| Study Director: | Dmitri Lissin, MD | Scilex Pharmaceuticals, Inc. |
Additional Information:
| Responsible Party: | Semnur Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT03372161 |
| Other Study ID Numbers: |
SP-102-02 |
| First Posted: | December 13, 2017 Key Record Dates |
| Last Update Posted: | May 21, 2020 |
| Last Verified: | May 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Scilex Pharmaceuticals, Inc. ( Semnur Pharmaceuticals, Inc. ):
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lumbosacral radicular pain sciatica leg pain |
Additional relevant MeSH terms:
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Radiculopathy Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |