Status:
SUSPENDED
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury
Lead Sponsor:
Eusol Biotech Co., Ltd.
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
15-65 years
Phase:
PHASE3
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 me...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects of either sex and 15-65 years of age.
- Subjects have spinal cord injury and the subjects must be categorized as Grade A or B by the ASIA Impairment Scale.
- Subjects have adequate heart, lung, kidney and liver function.
- Subjects are able to give voluntary and dated informed consent prior to enrollment.
- Exclusion Criteria
- Penetration SCI
- Brain damage or multiple injuries
- History of congenital or acquired abnormalities in the spinal cavity
- History of congenital or acquired immunodeficiency disorders
- History of malignancies or positive results
- Current serious/uncontrollable infections or others serious diseases
- Pregnant or lactating women
- Allergy to ES135 or any of its excipients
- Unable to obtain informed consent from subject
Exclusion
Key Trial Info
Start Date :
March 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03229031
Start Date
March 7 2018
End Date
December 31 2026
Last Update
May 8 2024
Active Locations (3)
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1
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
2
Far Eastern Memorial Hospital
New Taipei City, Taiwan
3
Taipei Veterans General Hospital
Taipei, Taiwan