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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 : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Eusol Biotech Co., Ltd.

July 20, 2017
July 25, 2017
July 25, 2018
March 7, 2018
December 31, 2022   (Final data collection date for primary outcome measure)
Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores [ Time Frame: 48 weeks ]
Same as current
Complete list of historical versions of study NCT03229031 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Randomized, Double-blind
Primary Purpose: Treatment
Spinal Cord Injuries
Drug: ES135
ES135 will be administered via intrathecal
  • Experimental: ES135
    Intervention: Drug: ES135
  • Placebo Comparator: Placebo
    Intervention: Drug: ES135
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Same as current
December 31, 2024
December 31, 2022   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects of either sex and 18-65 years of age.
  2. Subjects have spinal cord injury and the subjects must be categorized as Grade A 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact: Jolly Huang +88627185128 ext 31 jolly@eusol.com.tw
Taiwan
 
 
NCT03229031
ES135-1601
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Eusol Biotech Co., Ltd.
Eusol Biotech Co., Ltd.
Not Provided
Not Provided
Eusol Biotech Co., Ltd.
July 2018

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