Clinical Trial: Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Subarachno

Brief Summary: This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.

Detailed Summary:
Sponsor: Edge Therapeutics Inc

Current Primary Outcome: Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale [Primary Efficacy Endpoint] [ Time Frame: 90 Days ]

Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90


Original Primary Outcome: Same as current

Current Secondary Outcome: Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment [Secondary Efficacy Endpoint] [ Time Frame: 90 Days ]

Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment (MoCA) at Day 90


Original Secondary Outcome: Same as current

Information By: Edge Therapeutics Inc

Dates:
Date Received: May 26, 2016
Date Started: July 2016
Date Completion: August 2018
Last Updated: May 1, 2017
Last Verified: May 2017