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 ]
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 ]
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