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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

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ClinicalTrials.gov Identifier: NCT03229031
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Eusol Biotech Co., Ltd.

Tracking Information
First Submitted Date  ICMJE July 20, 2017
First Posted Date  ICMJE July 25, 2017
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE March 7, 2018
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2017)
Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores [ Time Frame: 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Randomized, Double-blind
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE Drug: ES135
ES135 will be administered via intrathecal
Study Arms  ICMJE
  • Experimental: ES135
    Intervention: Drug: ES135
  • Placebo Comparator: Placebo
    Intervention: Drug: ES135
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2020)
160
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2017)
100
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jolly Huang +88627185128 ext 31 jolly@eusol.com.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03229031
Other Study ID Numbers  ICMJE ES135-1601
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eusol Biotech Co., Ltd.
Study Sponsor  ICMJE Eusol Biotech Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eusol Biotech Co., Ltd.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP