Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage (NEWTON2)

Edge Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Treatments: Drug: EG-1962 (nimodipine microparticles); Drug: Enteral Nimodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02790632

EG-01-1962-03

Details and patient eligibility

About

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

Enrollment: 374 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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

1. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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374 participants in 2 patient groups

EG-1962 Group

Experimental group

Description:

* 1 dose of intraventricular EG-1962 (nimodipine microparticles) 600 mg * Up to 21 days of placebo capsules/tablets

Treatment:

Drug: EG-1962 (nimodipine microparticles)

Enteral Nimodipine Group

Active Comparator group

Description:

* 1 dose of intraventricular normal saline * Up to 21 days of oral nimodipine capsules/tablets

Treatment:

Drug: Enteral Nimodipine