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low recruitment rate
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ES135 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ES135 | Drug | ES135 will be administered via intrathecal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Veterans General Hospital | Kaohsiung City | Taiwan | ||||
| Far Eastern Memorial Hospital |
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Randomized, Double-blind
| New Taipei City |
| Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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