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Multicenter, Double-blind, Randomized, Placebo Controlled, Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301), in Patients With Severe Traumatic Brain Injury (TBI)

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Trial Profile

Multicenter, Double-blind, Randomized, Placebo Controlled, Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301), in Patients With Severe Traumatic Brain Injury (TBI)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 23 Apr 2025

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At a glance

  • Drugs Amantadine (Primary)
  • Indications Traumatic brain injuries
  • Focus Adverse reactions
  • Sponsors Shinkei Therapeutics

Most Recent Events

  • 20 Apr 2025 Planned End Date changed from 1 Jun 2025 to 1 Jul 2025.
  • 20 Apr 2025 Planned primary completion date changed from 1 Mar 2025 to 1 Jul 2025.
  • 24 Oct 2024 Planned End Date changed from 1 Nov 2024 to 1 Jun 2025.

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