Einstein Montefiore

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

Purpose

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

Condition

Subarachnoid Hemorrhage, Aneurysmal

Eligibility

Eligible Ages: Between 18 Years and 75 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Ruptured saccular aneurysm confirmed by angiography and repaired by neurosurgical clipping or endovascular coiling 2. External ventricular drain in place 3. Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fisher scale 4. WFNS grade 2, 3, or 4

Exclusion Criteria

Major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion or inability to secure the ruptured aneurysm 2. Angiographic vasospasm prior to randomization 3. Evidence of a cerebral infarction with neurological deficit

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental EG-1962 Group	1 dose of intraventricular EG-1962 (nimodipine microparticles) 600 mg Up to 21 days of placebo capsules/tablets	Drug: EG-1962 (nimodipine microparticles) Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days
Active Comparator Enteral Nimodipine Group	1 dose of intraventricular normal saline Up to 21 days of oral nimodipine capsules/tablets	Drug: Enteral Nimodipine Enteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD

More Details

Status: Terminated
Sponsor: Edge Therapeutics Inc

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.