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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03229031
• Other study ID #: ES135-1601
• Status: Suspended
• Phase: Phase 3
• Start date: March 7, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Eusol Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 160
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Drug:
• ES135
ES135 will be administered via intrathecal

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Eusol Biotech Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores		48 weeks