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Study of NNZ-2566 in Patients With Traumatic Brain Injury

NCT00805818 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2018-02-05

No results posted yet for this study

Summary

The purpose of this study is to determine whether NNZ-2566 is safe and effective in the treatment of Traumatic Brain Injury (TBI).

Conditions

  • Brain Injuries

Interventions

DRUG

NNZ-2566

Solution for intravenous infusion. 20 mg/kg intravenous bolus infusion over 10 minutes followed by a continuous intravenous infusion of 1, 3, or 6 mg/kg/h for a total of 72 consecutive hours.

DRUG

Placebo

Sodium Chloride 0.9% Injection

Sponsors & Collaborators

  • Neuren Pharmaceuticals Limited

    lead INDUSTRY

Principal Investigators

  • Ross R Bullock, M.D., PhD · University of Miami, Lois Pope Life Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00805818 on ClinicalTrials.gov