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Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

NCT03372161 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 401

Last updated 2022-09-19

Study results available
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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 medication 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.

Conditions

  • Lumbosacral Radicular Pain

Interventions

DRUG

SP-102

injection

DRUG

Placebo

injection

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Semnur Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Scilex Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Dmitri Lissin, MD · Scilex Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-08
Primary Completion
2021-08-20
Completion
2022-01-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03372161 on ClinicalTrials.gov