Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

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.

Timeline

Start

2017-12-08

Primary completion

2021-08-20

Completion

2022-01-06

Outcome

Met primary endpoint

release “The study met its primary endpoint with a highly statistically significant reduction in average daily leg pain in patients receiving SEMDEXATM compared to placebo (p<0.001).” gcs-web.com ↗

release “This Phase 3 study met primary and important key secondary endpoints, with SP-102 (SEMDEXA™) treatment” gcs-web.com ↗

release “Semnur has completed a Phase 3 trial for SP-102, which met primary and important key secondary endpoints” gcs-web.com ↗

Publications

• Miller A, Candido KD, Knezevic NN, Rivera J, Lunseth P, Levinson DJ, Formoso F, Solanki D, Tavel E, Krull A, Radnovich R, Burkhead D, Souza D, Helm S, Katz N, Dworkin RH, Cohen SP, Rathmell JP, Buvanendran A, Levin J, Stannard E, Ambrose C, Jaros M, Vought K, Lissin D. A randomized, placebo-controlled trial of long-acting dexamethasone viscous gel delivered by transforaminal injection for lumbosacral radicular pain. Pain. 2024 Dec 1;165(12):2762-2773. doi: 10.1097/j.pain.0000000000003287. Epub 2024 Jun 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SP-102	Unknown	—	Other

Indications