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

NCT02872428 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-11-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Valproic Acid

By infusion over 1 hour

DRUG

Isotonic saline solution

By infusion over 1 hour

Sponsors & Collaborators

  • Dr. Hasan Alam

    lead OTHER

Principal Investigators

  • Hasan Alam, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-09-29
Completion
2017-09-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02872428 on ClinicalTrials.gov