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Safety and Tolerability Study of EG-1962 in Aneurysmal Subarachnoid Hemorrhage

NCT01893190 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2018-02-05

No results posted yet for this study

Summary

Phase 1/2a Multicenter, Controlled, Randomized, Open Label, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study Comparing EG-1962 and Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage

Conditions

  • Ruptured Cerebral Aneurysm
  • Ruptured Berry Aneurysm

Interventions

DRUG

Nimodipine

Based upon Investigator Judgement

DRUG

Nimodipine Microparticles

Based upon Investigator Judgement

Sponsors & Collaborators

  • Edge Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Daniel Hanggi · HHU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States
  • Canada
  • Czechia
  • Finland

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 NCT01893190 on ClinicalTrials.gov