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

Primary Purpose

Spinal Cord Injuries

Status
Suspended
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
ES135
Sponsored by
Eusol Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord, spinal cord injury

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Veterans General Hospital
  • Far Eastern Memorial Hospital
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ES135

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores

Secondary Outcome Measures

Full Information

First Posted
July 20, 2017
Last Updated
April 20, 2023
Sponsor
Eusol Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03229031
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Suspended
Why Stopped
low recruitment rate
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eusol Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
spinal cord, spinal cord injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Randomized, Double-blind
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ES135
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ES135
Intervention Description
ES135 will be administered via intrathecal
Primary Outcome Measure Information:
Title
Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this 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

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