The goal of this study is to measure the effectiveness of a single dose of SP-102, an experimental medication, as a pain reliever. The side effects of the medication will also be investigated. Patients will receive one dose of the medication, and possibly a second dose 1 month after the initial treatment.
400 subjects will be enrolled in the study. The primary purpose of the trial is treatment. The study began on December 8, 2017 and is estimated to be completed by December 1, 2020.
- 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.
- 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.
This study will take place at numerous locations including Alabama, Arizona, Florida, Georgia, Idaho, Illinois, Massachusetts, Michigan, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, South Carolina, Texas, and Utah.
Sponsors / Collaborators
This study is sponsored by Semnur Pharmaceuticals, Inc., Worldwide Clinical Trials, and Scilex Pharmaceuticals, Inc. The study director is Dmitri Lissin, MD. of Scilex Pharmaceuticals, Inc.
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