drugset / Trial / NCT03229031

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury

NCT03229031 ↗

Phase 3 Suspended 160 enrolled Eusol Biotech Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

To demonstrate the superior effect of ES135 combined with spinal cord repairing surgery, compared to a placebo control with spinal cord repairing surgery, on post-surgery motor function recovery as measured by the changes from baseline of ISNCSCI Motor Scores in subjects

Timeline

Start
2018-03-07
Primary completion
2024-12-31
Completion
2026-12-31

Outcome

Outcome not reported

Stopped (Enrollment): “low recruitment rate”

Drugs

EvaluationDrugModalityDoseRoute
Subject ES135 Unknown — Intrathecal

Indications