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A Safety and Efficacy Study of NNZ-2566 in Patients With Mild Traumatic Brain Injury (mTBI)

NCT02100150 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

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 well tolerated in the treatment of mTBI in adolescents and adults.

Conditions

  • Concussion

Interventions

DRUG

NNZ-2566

Glycyl-L-2-Methylpropyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (3g in 30 milliliter vials) for reconstitution with strawberry flavored solution 0.5% v/v in Water for Injection.

DRUG

Placebo

Strawberry flavored solution 0.5% v/v in Water for Injection

Sponsors & Collaborators

  • Neuren Pharmaceuticals Limited

    lead INDUSTRY

Principal Investigators

  • Wesley R Cole, Ph.D · Fort Bragg

  • Kurt Denninghoff, MD · University of Arizona

  • Alex Hishaw, MD · University of Arizona

  • Brian O'Neil, MD · Detroit Receiving Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-06-30
Completion
2016-06-30

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 NCT02100150 on ClinicalTrials.gov