Clinical Trials Logo
  1. Home
  2. Concussion
  3. NCT02100150

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

Concussion Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of NNZ-2566 in the Acute Treatment of Adolescents and Adults With Mild Traumatic Brain Injury (mTBI)

Clinical Trial 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.

Clinical Trial Description

Traumatic brain injury (TBI) is an injury to the head caused by an external trauma that can lead to brain cell death, inflammation, edema, hemorrhage, and disruption of normal brain cell function. mTBI frequently results in persistent functional impairment including problems with cognitive function, memory, mood, and other personality disorders.

There are currently no drugs available to reduce the brain damage or sequelae that result from TBI. Clearly, a safe and effective treatment for concussion injury and all forms of TBI would be an important development for military personnel as well as the general population.

This study will investigate the safety and tolerability of treatment with oral administration of NNZ-2566 at 35 mg/kg or 70 mg/kg BID in adolescents and adults with mTBI. The study also will also investigate measures of efficacy during treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02100150
Study type Interventional
Source Neuren Pharmaceuticals Limited
Contact
Status Terminated
Phase Phase 2
Start date September 2014
Completion date June 2016
View Details
See also
  Status Clinical Trial Phase
Completed NCT03304327 - Mindfulness and Yoga Training for Athletes With Concussion (MYTAC) N/A
Completed NCT05562544 - EEG Diagnostic for Repetitive Sub-concussive Head Impacts
Terminated NCT02988609 - Concussion in Rugby Players: a Pilot Study of Neural Recovery Using fMRI N/A
Completed NCT02710123 - Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion N/A
Active, not recruiting NCT01874847 - PLAY GAME: Post-concussion Syndrome in Youth - Assessing the GABAergic Effects of Melatonin Phase 2/Phase 3
Completed NCT02262507 - Concussion Device Audiological Measures N/A
Completed NCT01903525 - DHA For The Treatment of Pediatric Concussion Related to Sports Injury Phase 1
Enrolling by invitation NCT05948501 - The Effects of Concussion on Gait and Posture in Individuals With Peripheral Vision Loss
Withdrawn NCT02643836 - Pulsed Electromagnetic Field (PEMF) Therapy for Post-Concussive Syndrome N/A
Recruiting NCT03360786 - Primary Prevention of Concussion in Youth Ice Hockey Players N/A
Recruiting NCT03710109 - Evaluation of an EEG Based Concussion System
Not yet recruiting NCT02930395 - Blood Biomarkers for the Management of Concussion in Professional Rugby Players N/A
Completed NCT02278029 - Driving Performance of Teenage Patients With mTBI: a Longitudinal Assessment N/A
Completed NCT02271451 - Q-collar and Brain Injury Biomarkers N/A
Completed NCT02268240 - Care for Post-Concussive Symptoms N/A
Completed NCT02268058 - Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children N/A
Active, not recruiting NCT03608722 - Video Games to Track Cognitive Health N/A
Completed NCT02660164 - A Study to Assess the Effectiveness of the Nautilus BrainPulse™ as an Aid in the Diagnosis of Concussion
Completed NCT02556177 - Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 N/A
Completed NCT02344446 - Physical Therapy Intervention for Extended Physical Symptoms After a Sports-related Concussion N/A