NCT02790632

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 374 (estimated)
• Sponsor: Edge Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Subarachnoid Hemorrhage, Aneurysmal

Interventions

Type	Name	Description
DRUG	EG-1962 (nimodipine microparticles)	Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days
DRUG	Enteral Nimodipine	Enteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2016-06-06
• Last updated: 2018-07-26

Locations

79 sites across 11 countries: United States, Australia, Austria, Canada, Czechia, Finland, Germany, Hong Kong, Israel, New Zealand, Singapore