drugset / Trial / NCT02872428

A Study to Evaluate the Safety and Tolerability of Valproic Acid in Trauma Patients(Part 2)

NCT02872428

Phase 1 Terminated 1 enrolled Dr. Hasan Alam
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

EvaluationDrugModalityDoseRoute
Subject Valproic Acid Small molecule 130 mg/kg Intravenous
Subject Valproic Acid Small molecule 140 mg/kg Intravenous