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Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain Injury

NCT02794168 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2021-10-11

No results posted yet for this study

Summary

This study evaluates the efficacy of an infusion of Ronopterin (VAS203) on clinical outcome in patients with moderate and severe traumatic brain injury. Half of the participants will receive Ronopterin (VAS203), while the other half will receive placebo.

Conditions

Interventions

DRUG

VAS203

Treatment

DRUG

Saline

Placebo

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • veriNOS operations GmbH

    lead INDUSTRY

Principal Investigators

  • Erich Schmutzhard, Prof. MD · Medical University Innsbruck

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Austria
  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02794168 on ClinicalTrials.gov