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

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

Study Overview

• Status: Suspended
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Drug: ES135

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jolly Huang; Phone Number: 31 +88627185128; Email: jolly@eusol.com.tw

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Kaohsiung Veterans General Hospital
  • New Taipei City, Taiwan
    • Far Eastern Memorial Hospital
  • Taipei, Taiwan
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: ES135; ES135 will be administered via intrathecal
Experimental: ES135	Drug: ES135; ES135 will be administered via intrathecal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores	48 weeks

Collaborators and Investigators

• Sponsor: Eusol Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 23, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: spinal cord, spinal cord injury
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: ES135-1601

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No