Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02794168 | Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain Injury | PHASE3 | COMPLETED | 224 | — | — | Jun 1, 2016 | Jun 30, 2020 | Oct 11, 2021 | 29 | Austria, France +3 |
clinical outcome questionnaire
| Arm | Type | Description |
|---|---|---|
| VAS203 (Ronopterin) | EXPERIMENTAL | Intravenous infusion of 17 mg/kg VAS203 over 48 hours, daily dose 8.5 mg/kg |
| Saline | PLACEBO_COMPARATOR | Intravenous infusion of physiological saline over 48 hours |
| Name | Type | Description |
|---|---|---|
| VAS203 | DRUG | Treatment |
| Saline | DRUG | Placebo |
Inclusion Criteria: 1. Written informed consent from patient's legal guardian or legal representative or deferred consent procedure, according to local requirements 2. 18 - 60 years of age, inclusive 3. Expected to survive more than 24 hours after admission 4. Traumatic Brain Injury (TBI) within th...