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

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

Official title:

Multicenter, Controlled, Randomized, Safety and Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02893826
• Other study ID #: EG-01-1962-04
• Status: Terminated
• Phase: Phase 1
• Start date: September 2016
• Est. completion date: March 2018

Study information

• Verified date: July 2018
• Source: Edge Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Intervention

Drug:
• EG-1962 (nimodipine microparticles)

• Enteral Nimodipine

Locations

Country	Name	City	State
Canada	University of Alberta Hospital/Mackenzie Health Sciences Centre	Edmonton	Alberta
United States	University of Maryland Medical Systems	Baltimore	Maryland
United States	Dignity Health; St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Edge Therapeutics Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Extended Glasgow Outcome Scale (GOSE)	Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90	Day 90
Other	Montreal Cognitive Assessment (MoCA)	Proportion of subjects with a favorable outcome measured on the Montreal Cognitive Assessment (MoCA) at Day 90	Day 90
Primary	Incidence and severity of adverse events		90 Days
Primary	Proportion of subjects with delayed cerebral infarctions present on CT at Day 30		30 Days
Secondary	Pharmacokinetic (PK) profile of EG-1962 as measured by maximum drug concentration in plasma (Cmax)		At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and daily thereafter until hospital discharge or Day 21, whichever occurs first and Day 30
Secondary	Pharmacokinetic (PK) profile of EG-1962 as measured by time to reach maximum drug concentration in plasma (Tmax)		At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and daily thereafter until hospital discharge or Day 21, whichever occurs first and Day 30
Secondary	Pharmacokinetic (PK) profile of EG-1962 as measured by steady state concentration (Css)		At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and daily thereafter until hospital discharge or Day 21, whichever occurs first and Day 30
Secondary	Pharmacokinetic (PK) profile of EG-1962 as measured by AUC area under the plasma concentration-time curve (AUC) from 0 to 24 hours (AUC024h)		At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours
Secondary	Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to Day 10 (AUC0-10)		At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and up to Day 10
Secondary	Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to Day 14 (AUC0-14)		At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and up to Day 14
Secondary	Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to last plasma concentration (AUC0-last)		At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and up to last plasma concentration