Back to results

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

Primary Purpose

Subarachnoid Hemorrhage, Aneurysmal

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

EG-1962 (nimodipine microparticles)

Enteral Nimodipine

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage, Aneurysmal focused on measuring Aneurysm, Ruptured, nimodipine, subarachnoid hemorrhage

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ruptured saccular aneurysm repaired by neurosurgical clipping
Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fischer scale
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:

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
Angiographic vasospasm prior to randomization
Evidence of cerebral infarction with neurological deficit

Sites / Locations

Dignity Health; St. Joseph's Hospital and Medical Center
University of California San Francisco
University of Maryland Medical Systems
University of Alberta Hospital/Mackenzie Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EG-1962 Group

Enteral Nimodipine Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence and severity of adverse events

Proportion of subjects with delayed cerebral infarctions present on CT at Day 30

Secondary Outcome Measures

Pharmacokinetic (PK) profile of EG-1962 as measured by maximum drug concentration in plasma (Cmax)

Pharmacokinetic (PK) profile of EG-1962 as measured by time to reach maximum drug concentration in plasma (Tmax)

Pharmacokinetic (PK) profile of EG-1962 as measured by steady state concentration (Css)

Pharmacokinetic (PK) profile of EG-1962 as measured by AUC area under the plasma concentration-time curve (AUC) from 0 to 24 hours (AUC024h)

Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to Day 10 (AUC0-10)

Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to Day 14 (AUC0-14)

Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to last plasma concentration (AUC0-last)

Full Information

NCT ID

NCT02893826

First Posted

August 25, 2016

Last Updated

July 24, 2018

Sponsor

Edge Therapeutics Inc

1. Study Identification

Unique Protocol Identification Number

NCT02893826

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Terminated

Why Stopped

Based on DMC recommendation to discontinue EG-01-1962-03

Study Start Date

September 2016 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Edge Therapeutics Inc

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Subarachnoid Hemorrhage, Aneurysmal

Keywords

Aneurysm, Ruptured, nimodipine, subarachnoid hemorrhage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EG-1962 Group

Arm Type

Experimental

Arm Description

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

Arm Title

Enteral Nimodipine Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

EG-1962 (nimodipine microparticles)

Other Intervention Name(s)

Single intracisternal adminstration

Intervention Type

Drug

Intervention Name(s)

Enteral Nimodipine

Other Intervention Name(s)

Administered for up to 21 days

Primary Outcome Measure Information:

Title

Incidence and severity of adverse events

Time Frame

90 Days

Title

Proportion of subjects with delayed cerebral infarctions present on CT at Day 30

Time Frame

30 Days

Secondary Outcome Measure Information:

Title

Pharmacokinetic (PK) profile of EG-1962 as measured by maximum drug concentration in plasma (Cmax)

Time Frame

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

Title

Pharmacokinetic (PK) profile of EG-1962 as measured by time to reach maximum drug concentration in plasma (Tmax)

Time Frame

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

Title

Pharmacokinetic (PK) profile of EG-1962 as measured by steady state concentration (Css)

Time Frame

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

Title

Pharmacokinetic (PK) profile of EG-1962 as measured by AUC area under the plasma concentration-time curve (AUC) from 0 to 24 hours (AUC024h)

Time Frame

At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours

Title

Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to Day 10 (AUC0-10)

Time Frame

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

Title

Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to Day 14 (AUC0-14)

Time Frame

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

Title

Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to last plasma concentration (AUC0-last)

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Extended Glasgow Outcome Scale (GOSE)

Description

Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90

Time Frame

Day 90

Title

Montreal Cognitive Assessment (MoCA)

Description

Proportion of subjects with a favorable outcome measured on the Montreal Cognitive Assessment (MoCA) at Day 90

Time Frame

Day 90

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ruptured saccular aneurysm repaired by neurosurgical clipping Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fischer scale 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: 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 Angiographic vasospasm prior to randomization Evidence of cerebral infarction with neurological deficit

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

R. Loch Macdonald, MD, PhD

Organizational Affiliation

Edge Therapeutics Inc

Official's Role

Study Chair

Facility Information:

Facility Name

Dignity Health; St. Joseph's Hospital and Medical Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

University of California San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

University of Maryland Medical Systems

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

University of Alberta Hospital/Mackenzie Health Sciences Centre

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32985652

Citation

Macdonald RL, Hanggi D, Ko NU, Darsaut TE, Carlson AP, Wong GK, Etminan N, Mayer SA, Aldrich EF, Diringer MN, Ng D, Strange P, Bleck T, Grubb R, Suarez JI. NEWTON-2 Cisternal (Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage): A Phase 2, Multicenter, Randomized, Open-Label Safety Study of Intracisternal EG-1962 in Aneurysmal Subarachnoid Hemorrhage. Neurosurgery. 2020 Dec 15;88(1):E13-E26. doi: 10.1093/neuros/nyaa430.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs