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

NCT02790632 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2018-07-26

No results posted yet for this study

Summary

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

Conditions

  • Subarachnoid Hemorrhage, Aneurysmal

Interventions

DRUG

EG-1962 (nimodipine microparticles)

Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days

DRUG

Enteral Nimodipine

Enteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD

Sponsors & Collaborators

  • Edge Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • R. Loch Macdonald, MD, PhD · Edge Therapeutics Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Czechia
  • Finland
  • Germany
  • Hong Kong
  • Israel
  • New Zealand
  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02790632 on ClinicalTrials.gov