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

Eusol Biotech

Status and phase: Suspended; Phase 3

Conditions: Spinal Cord Injuries

Treatments: Drug: ES135

Study type: Interventional

Funder types: Industry

Identifiers

NCT03229031

ES135-1601

Details and patient eligibility

About

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

Enrollment: 160 estimated patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups, including a placebo group

ES135

Experimental group

Treatment:

Drug: ES135

Placebo

Placebo Comparator group

Treatment:

Drug: ES135