NCT01366820

Study of NNZ-2566 in Patients With Traumatic Brain Injury Under EFIC

A Randomized, Double-Blind, Placebo-Controlled, Study of NNZ-2566 in Patients With Traumatic Brain Injury (TBI) Conducted Under an Exception From Informed Consent (EFIC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Neuren Pharmaceuticals Limited · Industry
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Moderate to severe traumatic brain injury frequently results in persistent problems with memory, attention span, mood and more complex brain functioning such as planning and organizing. There are currently no drugs available to reduce the brain damage or the persisting symptoms that result from TBI. The longer term goal of this study is to provide physicians with a safe and effective treatment for TBI

Conditions

• Brain Injuries

Interventions

Type	Name	Description
DRUG	NNZ-2566	Solution for intravenous infusion. Intravenous bolus infusion over 10 minutes followed by a continuous intravenous maintenance infusion for a total of 72 consecutive hours.
DRUG	Placebo	Sodium Chloride 0.9% Injection

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2011-06-06
• Last updated: 2018-02-05

Locations

6 sites across 1 country: United States