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
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
- 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.