Safety/Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With aSAH

Edge Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Subarachnoid Hemorrhage, Aneurysmal

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02893826

EG-01-1962-04

Details and patient eligibility

About

Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in the treatment of aneurysmal subarachnoid hemorrhage.

Enrollment: 6 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ruptured saccular aneurysm repaired by neurosurgical clipping
2. Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fischer scale
3. WFNS grade 1 or 2 assessed during the Pre-randomization Phase. If WFNS grade 2, must not require an EVD prior to aneurysm repair

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 cerebral infarction with neurological deficit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

6 participants in 2 patient groups

EG-1962 Group

Experimental group

Description:

1 dose of intracisternal EG-1962 (nimodipine microparticles) 600 mg

Treatment:

Drug: EG-1962 (nimodipine microparticles)

Enteral Nimodipine Group

Active Comparator group

Description:

Up to a total of 21 days of enteral nimodipine (including nimodipine received prior to randomization)

Treatment:

Drug: Enteral Nimodipine