CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 401 enrolled
Drug / intervention
SP-102 +1 moredrug
Likely dose
SP-102 lumbar epidural injection (specific dose not stated in protocol excerpt)AI-extracted
Key inclusion· 4
  • ✓Age 18 to 70 years inclusive
  • ✓Diagnosis of lumbosacral radicular pain (sciatica)
  • ✓Able to read, write, and understand English and provide informed consent
  • ✓Willing to use effective birth control if sexually active and of childbearing potential
Key exclusion· 5
  • ✕Prior lumbosacral back surgery or planned spine surgery during study
  • ✕Insulin-dependent diabetes mellitus
  • ✕Body mass index ≥40 kg/m²
  • ✕Radiologic evidence of condition that would compromise study outcomes

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03372161
NCT03372161Phase 3Completed
CompareCT.gov

Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)

Scilex Pharmaceuticals, Inc.·interventional·Posted Dec 13, 2017·Updated Sep 19, 2022

In Brief

A Phase 3 clinical trial evaluating SP-102 and Placebo for Lumbosacral Radicular Pain. Completed, enrolled 401 participants across 37 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLumbosacral Radicular Pain
CountriesUnited States
CollaboratorsWorldwide Clinical Trials, Semnur Pharmaceuticals, Inc.

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedDec 13, 2017
Enrollment StartDec 8, 2017
Primary CompletionAug 20, 2021
Study CompletionJan 6, 2022
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.6 years ago

Interventions

SP-102drug

injection

Placebodrug

injection