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

This study is currently recruiting participants.
Verified May 2017 by Edge Therapeutics Inc
Sponsor:
ClinicalTrials.gov Identifier:
NCT02790632
First Posted: June 6, 2016
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Edge Therapeutics Inc
  Purpose
This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.

Condition Intervention Phase
Subarachnoid Hemorrhage, Aneurysmal Drug: EG-1962 (nimodipine microparticles) Drug: Enteral Nimodipine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Edge Therapeutics Inc:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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

  • Delayed Cerebral Infarction [ Time Frame: 30 Days ]
    Proportion of subjects with delayed cerebral infarction present on CT scan at Day 30


Estimated Enrollment: 374
Study Start Date: July 2016
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790632


  Show 74 Study Locations
Sponsors and Collaborators
Edge Therapeutics Inc
Investigators
Study Chair: R. Loch Macdonald, MD, PhD Edge Therapeutics Inc
  More Information

Responsible Party: Edge Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02790632     History of Changes
Other Study ID Numbers: EG-01-1962-03
First Submitted: May 26, 2016
First Posted: June 6, 2016
Last Update Posted: November 6, 2017
Last Verified: May 2017

Keywords provided by Edge Therapeutics Inc:
Aneurysm, Ruptured
Nimodipine
Subarachnoid Hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Nimodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents