Trial Profile

A Randomized, Placebo-Controlled, Phase IIb Efficacy Trial of Ciclosporin (NeuroSTAT) for Moderate to Severe Traumatic Brain Injuries (TBI)

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 09 Jan 2024

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At a glance

04 Jan 2024 According to Owl Therapeutics media release, the company is currently in negotiations with a confidential source and key opinion leaders (KOLs) to fund this study.
10 May 2019 According to a NeuroVive Pharmaceutical media release, the US Food and Drug Administration (FDA) has approved Investigational New Drug application (IND) of NeuroSTAT in development for treatment of moderate to severe traumatic brain injury (TBI).
04 Oct 2018 According to a NeuroVive Pharmaceutical media release, the company plans to use innovative biomarkers (GFAP, UCH-L1, NF-L and Tau biomarkers) as outcome measures together with other new endpoints to establish proof of concept in this trial.Also, it expects to start this trial in 2019.

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