Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study Comparing EG-1962 to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage

Trial Profile

Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study Comparing EG-1962 to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage

Recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Dec 2017

At a glance

  • Drugs Nimodipine (Primary) ; Nimodipine
  • Indications Cerebral ischaemia; Subarachnoid haemorrhage
  • Focus Registrational; Therapeutic Use
  • Acronyms NEWTON 2
  • Sponsors Edge Therapeutics
  • Most Recent Events

    • 20 Nov 2017 This trial has been discontinued in Denmark.
    • 07 Nov 2017 According to an Edge Therapeutics media release, in September, the 150th patient was randomized in this trial. The achievement of this milestone triggered preparation for a pre-specified futility analysis by the study's external independent Data Monitoring Committee (DMC). Once the first 150 patients in this study complete their Day 90 follow-up assessments, the clinical data package will be compiled and submitted to the study's DMC to perform the futility analysis.
    • 01 Aug 2017 According to an Edge Therapeutics media release, the company look forward to the pre-planned futility analysis in late 2017, top-line efficacy interim analysis results in the first quarter of 2018 and top-line results from the full study in late 2018.
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