A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury
NCT ID: NCT03229031
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE3
160 participants
INTERVENTIONAL
2018-03-07
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ES135
ES135
ES135 will be administered via intrathecal
Placebo
ES135
ES135 will be administered via intrathecal
Interventions
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ES135
ES135 will be administered via intrathecal
Eligibility Criteria
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Inclusion Criteria
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
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
15 Years
65 Years
ALL
No
Sponsors
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Eusol Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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ES135-1601
Identifier Type: -
Identifier Source: org_study_id
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