SHINKEI TBI
Brief description of study
The overall objective of the study is to assess the safety and tolerability of MR-301 in improving rate of recovery in patients with severe non-penetrating Traumatic Brain Injury (TBI). The primary outcome variables are measurements of the frequency, severity, and type of drug-related adverse events and serious adverse events between treatment and placebo groups. The secondary outcome variables are the measurements of change from baseline in various neurological tests (GOS-E at Days 21 and 35; DRS scale at Days 5, 10, 15, and 21; CRS-R at Days 5, 10, 15, and 21; and FOUR everyday up to Day 21), time to ICU discharge to hospital floor, time to hospital discharge, mortality assessment at end of treatment period (Day 21), and mortality assessment at end of study period (Day 35).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: - 99 Years
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Gender: All
TBD
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