Recent Updates
Recently added Catalysts

VAS203

Phase 3

Traumatic Brain Injury | Small molecule | Neurology |Icon Plc|Last Updated: Oct 11, 2021

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment224

FDA Designations

No designations recorded

Clinical trial landscape

VAS203 · 1 trial · 1 indication

Phase 3 1
NCT02794168Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain InjuryTraumatic Brain Injury
COMPLETED224 Analytics
PHASE3COMPLETED
Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain Injury
Traumatic Brain InjuryUnlock trial analytics

Study Endpoints

Primary Endpoints

extended Glasgow Outcome Scale
6 months

clinical outcome questionnaire

Secondary Endpoints

Quality of life after brain injury (QOLIBRI)
6 months
QOLIBRI overall scale
6 months
extended Glasgow Outcome Scale
3 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VAS203 (Ronopterin)EXPERIMENTALIntravenous infusion of 17 mg/kg VAS203 over 48 hours, daily dose 8.5 mg/kg
SalinePLACEBO_COMPARATORIntravenous infusion of physiological saline over 48 hours

Interventions

NameTypeDescription
VAS203DRUGTreatment
SalineDRUGPlacebo
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites29

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...

Countries:AustriaFranceGermanySpainUnited Kingdom
Unlock Eligibility Criteria

Frequently asked questions about VAS203

What is VAS203 used for?

VAS203, also known as Ronopterin, is an investigational small molecule being studied for the treatment of traumatic brain injury. It is intended for patients with moderate and severe traumatic brain injury. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who is developing VAS203?

VAS203 is being developed by Icon Plc, a company traded on the NASDAQ under the ticker symbol ICLR. The drug is currently in Phase 3 clinical development for traumatic brain injury.

What phase is VAS203 in?

VAS203 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. A Phase 3 trial has been completed, but the drug remains under investigation.

What clinical trials is VAS203 in?

VAS203 has one completed Phase 3 clinical trial, identified as NCT02794168. This trial, titled 'Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain Injury,' enrolled 224 participants across Austria, France, Germany, Spain, and the United Kingdom.

Is VAS203 the same as Ronopterin?

Yes, VAS203 is also known as Ronopterin. The clinical trial for VAS203, NCT02794168, refers to the drug as Ronopterin in its title. Both names refer to the same investigational small molecule being studied for traumatic brain injury.