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NCT03229031 Clinical Trial

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
Secondary ID
Status Suspended
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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