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

July 24, 2018 updated by: Edge Therapeutics Inc

Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study Comparing EG-1962 to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

374

Phase

  • Phase 3

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

  • Australia
      • Adelaide, Australia, 5000
        • Royal Adelaide Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Kingswood, New South Wales, Australia, 02747
        • Nepean Hospital
  • Austria
      • Innsbruck, Austria, 06020
        • Medizinische Universitat Innsbruck/Tirol Universitatsklinik fur Neurologie
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital/Mackenzie Health Sciences Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Vancouver General Hospital
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
    • Quebec
      • Montréal, Quebec, Canada, H2L 4M1
        • Centre Hospitalier de l'Universite de Montreal (CHUM), Hopital Notre Dame
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital
  • Czechia
      • Ostrava, Czechia, 708 52
        • Faculty Hospital Ostrava
      • Prague, Czechia, 16902
        • Military University Hospital Prague
    • Hradec Kralov
      • Hradec Králové, Hradec Kralov, Czechia, 50005
        • Faculty Hospital Hradec Králové
    • South Moravian Region
      • Brno, South Moravian Region, Czechia, 62500
        • Faculty Hospital Brno
  • Finland
      • Helsinki, Finland, 00260
        • Helsinki University Hospital
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33521
        • Tampere University Hospital
  • Germany
      • Berlin, Germany, 10117
        • Neuro Intensive Care Unit 102i; Campus Charite Mitte (CCM)
      • Erlangen, Germany, 91054
        • Universitatsklinikum Erlangen, Neurologische Klinik, Koptkliniken
      • Essen, Germany, 45147
        • Klinik für Neurochirurgie des Universitätsklinikum Essen
      • Frankfurt am Main, Germany, 60528
        • Klinik für Neurochirurgie, Zentrum der Neurologie und Neurochirurgie, Goethe-Universitätsklinikum Frankfurt am Main
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg Eppendorf, Klinik und Poliklinik für Neurochirurgie, Neues Klinikum
      • Heidelberg, Germany, 69120
        • Neurochirurgische Klinik der Universität Heidelberg
      • Köln, Germany, 50937
        • Zentrum fur Neurochirurgie der Uniklinik Koln
      • Leipzig, Germany, 04013
        • Klinik und Poliklinik für Neurochirurgie des Universitatsklinikum Leipzig
      • Mannheim, Germany, 68167
        • Neurochirurgische Klinik, Universitatsmedizin Mannheim, Universität Heidelberg
      • Munchen, Germany, 81675
        • Neurochirurgische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universitat Munchen
      • Würzburg, Germany, 97080
        • Neutochirurgische Klinik und Poliklinik des Universitatsklinikum Wurzburg
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • New Kowloon, Hong Kong
        • Prince of Wales Hospital
  • Israel
      • Haifa, Israel, 3109606
        • Rambam Health Care Center
      • Jerusalem, Israel, 91120
        • Hadassah Hebrew University Medical Center
      • Ramat Gan, Israel
        • Sheba Medical Center
    • Petah-Tikva
      • Petaẖ Tiqwa, Petah-Tikva, Israel, 4941492
        • Rabin Medical Center
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
  • Singapore
      • Singapore, Singapore, 308433
        • National Neuroscience Institute
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama At Birmingham Hospital
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Dignity Health; St. Joseph's Hospital and Medical Center
    • California
      • Fresno, California, United States, 93701
        • University of California, San Francisco-Fresno
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • Keck Hospital of USC
      • Los Angeles, California, United States, 90095
        • David Geffen School of Medicine at UCLA
      • San Francisco, California, United States, 94143
        • UCSF
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital (YNHH)
    • Florida
      • Gainesville, Florida, United States, 32610
        • UF Health Shands Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center/Lyerly Neurosurgery
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Neurological Clinic
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60612-7232
        • University of Illinois Hospital and Health Sciences System
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Systems
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson University Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Hospital
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10075
        • Lenox Hill Hospital
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Hospitals Neuroscience Intensive Care Unit
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Pavilion
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Hospital for Neuroscience
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian Hospital
    • South Carolina
      • Charleston Air Force Base, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Semmes Murphey Neurological Clinic
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Campus
      • Richmond, Virginia, United States, 23298
        • VCU Medical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington, Harborview Medical Center

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 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

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EG-1962 Group
  • 1 dose of intraventricular EG-1962 (nimodipine microparticles) 600 mg
  • Up to 21 days of placebo capsules/tablets
Drug: EG-1962 (nimodipine microparticles)
Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days
Active Comparator: Enteral Nimodipine Group
  • 1 dose of intraventricular normal saline
  • Up to 21 days of oral nimodipine capsules/tablets
Drug: Enteral Nimodipine
Enteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale [Primary Efficacy Endpoint]
Time Frame: 90 Days
Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90
90 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment [Secondary Efficacy Endpoint]
Time Frame: 90 Days
Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment (MoCA) at Day 90
90 Days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 90 Days
Incidence and severity of adverse events in EG-1962 treated subjects compared to subjects treated with standard of care oral nimodipine
90 Days
Delayed Cerebral Infarction
Time Frame: 30 Days
Proportion of subjects with delayed cerebral infarction present on CT scan at Day 30
30 Days

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

July 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

May 26, 2016

First Submitted That Met QC Criteria

May 31, 2016

First Posted (Estimate)

June 6, 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-01-1962-03

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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