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

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: 10 May 2019

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At a glance

  • Drugs Ciclosporin (Primary)
  • Indications Traumatic brain injuries
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Sponsors NeuroVive Pharmaceutical
  • Most Recent Events

    • 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.
    • 06 Sep 2018 According to a NeuroVive Pharmaceuticals media release, the company had a pre-IND meeting with the FDA and the Formal Advice feedback from FDA supports the novel design proposed for this planned Phase II study.
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