drugset / Trial / NCT02872428
A Study to Evaluate the Safety and Tolerability of Valproic Acid in Trauma Patients(Part 2)
RandomizedParallel-groupTriple-blindTreatment
Summary
THIS IS THE SECOND PART OF A 2-PART STUDY. The purpose of the first part of this study was to determine the safety and tolerability of ascending doses of valproic acid (also known as Depacon) administered as intravenous infusion (IV) in doses ranging from 15 mg/kg to 250 mg/kg in healthy subjects. ID: VPA-C-002 The second part of the study will also be to determine the safety and tolerability of single ascending doses of valproic acid administered as IV in trauma subjects with hemorrhagic shock.
Timeline
- Start
- 2016-11
- Primary completion
- 2017-09-29
- Completion
- 2017-09-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Valproic Acid | Small molecule | 130 mg/kg | Intravenous |
| Subject | Valproic Acid | Small molecule | 140 mg/kg | Intravenous |