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NCT02790632: NEWTON2

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

Terminated Phase 3 Last updated 24 July 2018
What this trial tests

Phase 3 trial testing EG-1962 (nimodipine microparticles) in Subarachnoid Hemorrhage, Aneurysmal in 374 participants. Terminated before completion.

Timeline
1 July 2016
Primary endpoint
1 June 2018
1 June 2018

Quick facts

Lead sponsorEdge Therapeutics Inc
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment374
Start date1 July 2016
Primary completion1 June 2018
Estimated completion1 June 2018
Sites79 locations across United States, Australia, Austria, Canada, Czechia, Finland, Germany, Hong Kong

Drugs / interventions tested

Conditions studied

Sponsor

Edge Therapeutics Inc — full company profile →

Who can join

Adults 18 to 75, any sex, with Subarachnoid Hemorrhage, Aneurysmal. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Nimodipine Reappraised: An Old Drug With a Future.
    Carlson AP, Hänggi D, Macdonald RL, Shuttleworth CW. · · 2020 · cited 97× · PMID 31560289 · DOI 10.2174/1570159x17666190927113021
  2. Single-Dose Intraventricular Nimodipine Microparticles Versus Oral Nimodipine for Aneurysmal Subarachnoid Hemorrhage.
    Carlson AP, Hänggi D, Wong GK, Etminan N, et al · · 2020 · cited 44× · PMID 32138631 · DOI 10.1161/strokeaha.119.027396
  3. Clinical Trial Protocol: 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 [NEWTON-2 (Nimodipine Microparticles to
    Hänggi D, Etminan N, Mayer SA, Aldrich EF, et al · · 2019 · cited 19× · PMID 30014184 · DOI 10.1007/s12028-018-0575-z
  4. MEK1/2 inhibitor U0126, but not nimodipine, reduces upregulation of cerebrovascular contractile receptors after subarachnoid haemorrhage in rats.
    Christensen ST, Johansson SE, Radziwon-Balicka A, Warfvinge K, et al · · 2019 · cited 11× · PMID 30978262 · DOI 10.1371/journal.pone.0215398

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Data sources for this page

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