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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 : Not yet recruiting
First Posted : July 25, 2017
Last Update Posted : July 25, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Drug: ES135 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Randomized, Double-blind
Primary Purpose: Treatment
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
Anticipated Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ES135 Drug: ES135
ES135 will be administered via intrathecal
Placebo Comparator: Placebo Drug: ES135
ES135 will be administered via intrathecal

Outcome Measures

Primary Outcome Measures :
  1. Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores [ Time Frame: 48 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
More Information

Responsible Party: Eusol Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT03229031     History of Changes
Other Study ID Numbers: ES135-1601
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eusol Biotech Co., Ltd.:
spinal cord, spinal cord injury

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System