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

July 24, 2018 updated by: Edge Therapeutics Inc

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital/Mackenzie Health Sciences Centre
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Dignity Health; St. Joseph's Hospital and Medical Center
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EG-1962 Group
1 dose of intracisternal EG-1962 (nimodipine microparticles) 600 mg
Drug: EG-1962 (nimodipine microparticles)
Other Names:
  • Single intracisternal adminstration
Active Comparator: Enteral Nimodipine Group
Up to a total of 21 days of enteral nimodipine (including nimodipine received prior to randomization)
Drug: Enteral Nimodipine
Other Names:
  • Administered for up to 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events
Time Frame: 90 Days
90 Days
Proportion of subjects with delayed cerebral infarctions present on CT at Day 30
Time Frame: 30 Days
30 Days

Secondary Outcome Measures

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

Outcome Measure
Measure Description
Time Frame
Extended Glasgow Outcome Scale (GOSE)
Time Frame: Day 90
Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90
Day 90
Montreal Cognitive Assessment (MoCA)
Time Frame: Day 90
Proportion of subjects with a favorable outcome measured on the Montreal Cognitive Assessment (MoCA) at Day 90
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edge Therapeutics Inc

Investigators

  • Study Chair: R. Loch Macdonald, MD, PhD, Edge Therapeutics Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EG-01-1962-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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