Corticosteroid Lumbar Epidural Analgesia for Radicular Pain 2

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Lumbosacral Radicular Pain

In brief

This is a research study of SP-102, an experimental medication designed to relieve pain in patients with moderate to severe sciatica (pain in the lower back, hips, buttocks and legs). SP-102, placebo (a medication that looks like SP-102 but does not contain any active ingredient), or an active comparator (dexamethasone sodium phosphate) is given once by the participant's healthcare professional. If a participant meets qualifications, each participant will have the option of receiving one supplemental open-label injection of SP-102, greater than four weeks and up to twenty weeks after their first injection. The purpose of the study is to measure how well a single injection of the experimental medication, SP-102, relieves pain versus placebo. The study will also measure how well SP-102 relieves pain versus an active comparator medication (dexamethasone sodium phosphate). The study will also investigate the side effects of SP-102.

Key facts

Study ID

NCT07579351

Run by

Semnur Pharmaceuticals, Inc.

People needed

755

Starts

2026-08-01

Expected to finish

2029-01-01

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 75 years (inclusive) at the Screening Visit.
• A diagnosis of lumbosacral radicular pain (sciatica) present for at least 6 weeks and not more than 9 months prior to the Screening Visit.
• Clinical symptoms consistent with the imaging (MRI)
• 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.
• Day 1 Inclusion:
• As calculated by the eDiary system, during the 7 days (D-7 to D-1) immediately prior to the Baseline Visit, the participant:
• Completed the current, worst, and daily average NPRS scores (in the affected leg, non-affected leg, and lower back) in the eDiary on at least 6 out of the 7 days during the Baseline Period.
• Meets the NPRS average daily pain score criteria,
• Has a mean (at Baseline Visit) NPRS worst pain score in the affected leg that is greater than the mean worst pain score in lower back.
• Participant continues to demonstrate a clear understanding of how to complete the eDiary.
• Participant remains an appropriate candidate for trial participation in the opinion of the Investigator.
• Participant continues to meet all the screening inclusion criteria and none of the exclusion criteria. -

You may not qualify if…

• Has a body mass index ≥40 kg/m2.
• Has radiologic evidence of a condition that would compromise study outcomes:
• Spinal cord tumor (intra- or extradural) or hematoma. Epidural or intrathecal abscess. Systemic infection.
• 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 any contradiction to performing MRI (such as coronary pacemakers and implantable cardioverter-defibrillators [ICDs], metallic foreign bodies, neuro and spinal cord stimulators).
• Has history of malignancy or evidence of malignancy, within 5 years of Screening Visit.
• Has significant motor impairment
• Has regular use of opioid doses > 30 mg morphine equivalents per day for more than 2 days per week in the 30 days prior to the Screening Visit.
• Involvement in an ongoing worker's compensation claim, disability claim, or litigation related to any pain problem, receiving payments for a settled claim, awaiting pending payment for a settled claim, or any potential secondary gain in the opinion of the Investigator.

Full record on ClinicalTrials.gov

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