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

Phase 3

Suspended

• Conditions: Spinal Cord Injuries
• Interventions: Drug: ES135

• Registration Number: NCT03229031
• Lead Sponsor: Eusol Biotech Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-23
• Study First Posted: 2017-07-25
• Study Start: 2018-03-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Subjects of either sex and 15-65 years of age.
2. Subjects have spinal cord injury and the subjects must be categorized as Grade A or B by the ASIA Impairment Scale.
3. Subjects have adequate heart, lung, kidney and liver function.
4. Subjects are able to give voluntary and dated informed consent prior to enrollment.

Exclusion Criteria

1. Penetration SCI
2. Brain damage or multiple injuries
3. History of congenital or acquired abnormalities in the spinal cavity
4. History of congenital or acquired immunodeficiency disorders
5. History of malignancies or positive results
6. Current serious/uncontrollable infections or others serious diseases
7. Pregnant or lactating women
8. Allergy to ES135 or any of its excipients
9. Unable to obtain informed consent from subject

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ES135	ES135	-
Placebo	ES135	-

Primary Outcome Measures

Name	Time	Method
Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores	48 weeks

Trial Locations

Locations (3)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan

Far Eastern Memorial Hospital; 🇨🇳 New Taipei City, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan