Study Stopped
low recruitment rate
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury
1 other identifier
interventional
160
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2018
Longer than P75 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2017
CompletedFirst Posted
Study publicly available on registry
July 25, 2017
CompletedStudy Start
First participant enrolled
March 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedMay 8, 2024
May 1, 2024
6.8 years
July 20, 2017
May 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores
48 weeks
Study Arms (2)
ES135
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Far Eastern Memorial Hospital
New Taipei City, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Randomized, Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2017
First Posted
July 25, 2017
Study Start
March 7, 2018
Primary Completion
December 31, 2024
Study Completion (Estimated)
December 31, 2026
Last Updated
May 8, 2024
Record last verified: 2024-05