Advertisement

Topics

Study of Citicoline for the Treatment of Traumatic Brain Injury (COBRIT)

2014-08-26 22:35:35 | BioPortfolio

Summary

The Citicoline Brain Injury Treatment (COBRIT) is a randomized, double-blind, placebo controlled, multi-center trial of the effects of 90 days of citicoline on functional outcome in patients with complicated mild, moderate and severe traumatic brain injury.

Description

Traumatic brain injury (TBI) is a major cause of death and disability. In the United States alone approximately 1.4 million sustain a TBI each year, of which 50,000 people die, and over 200,000 are hospitalized. Despite numerous prior clinical trials no standard pharmacotherapy for the treatment of TBI has been established in either the acute or post acute setting. Citicoline is a naturally occurring endogenous compound. This compound offers the potential of employing neuroprotection, neuro-recovery and neurofacilitation to enhance recovery after TBI.

The primary goal of this study is to assess the efficacy of citicoline compared to placebo on functional and cognitive outcome in participants with traumatic brain injury.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Traumatic Brain Injury

Intervention

citicoline

Location

University of Alabama at Birmingham
Birmingham
Alabama
United States
35294-3295

Status

Recruiting

Source

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-26T22:35:35-0400

Clinical Trials [1213 Associated Clinical Trials listed on BioPortfolio]

Multimodal Neurodiagnostic Imaging of Traumatic Brain Injury and Post-Traumatic Stress Disorder

The purpose of this study is to determine whether the brains of persons with and without traumatic brain injury differ in a meaningful way when advanced technology images of the brain are ...

Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury (TBI)

The study will explore the neurocognitive effect of four weeks of treatment with amantadine versus placebo in patients with traumatic brain injury using the Interval Bisection Timing Task....

Traumatic Brain Injury Feasibility Study (EPIC-011)

The purpose of this research study is to evaluate whether data made by the ClearView System can be used to detect whether someone has a traumatic brain injury and how severe the injury is.

Severe Traumatic Brain Injury

The aim of the study is to measure the effect of Finnish physician-staffed EMS unit treatment methods on traumatic brain injury (TBI) patient prognosis.

Traumatic Brain Injury and Effects of Acute Cyclosporine A

This is a prospective, randomized, placebo-controlled study about Cyclosporine A (CSP) and traumatic brain injury (TBI). Cyclosporine A is a drug already marketed and available for other...

PubMed Articles [11299 Associated PubMed Articles listed on BioPortfolio]

Systematic review of depression in mild traumatic brain injury: study protocol.

Of the over 1 million reported cases of traumatic brain injuries reported annually in the USA, a sizeable proportion are characterized as mild. Although it is generally well-accepted that most people ...

Day of injury CT and late MRI findings: Cognitive outcome in a paediatric sample with complicated mild traumatic brain injury.

Complicated mild traumatic brain injury (mTBI) or cmTBI is based on the presence of visibly identifiable brain pathology on the day-of-injury computed tomography (CT) scan. In a paediatric sample the ...

Limited usefulness of the Rey Fifteen-Item Test in detection of invalid performance in veterans suspected of mild traumatic brain injury.

This study explored using the FIT as a measure of performance validity among veterans undergoing neuropsychological evaluation for mild traumatic brain injury (mTBI).

Low-dose levetiracetam for seizure prophylaxis after traumatic brain injury.

The primary objective of this study was to determine the effectiveness of a lower dose of levetiracetam (500 mg every 12 hours) to prevent early seizures after traumatic brain injury (TBI). It was hyp...

Radiologic Determination of Corpus Callosum Injury in Patients with Mild Traumatic Brain Injury and Associated Clinical Characteristics.

To investigate the incidence of corpus callosum injury (CCI) in patients with mild traumatic brain injury (TBI) using brain MRI. We also performed a review of the clinical characteristics associated w...

Medical and Biotech [MESH] Definitions

Prolonged unconsciousness from which the individual cannot be aroused, associated with traumatic injuries to the BRAIN. This may be defined as unconsciousness persisting for 6 hours or longer. Coma results from injury to both cerebral hemispheres or the RETICULAR FORMATION of the BRAIN STEM. Contributing mechanisms include DIFFUSE AXONAL INJURY and BRAIN EDEMA. (From J Neurotrauma 1997 Oct;14(10):699-713)

Acute and chronic (see also BRAIN INJURIES, CHRONIC) injuries to the brain, including the cerebral hemispheres, CEREBELLUM, and BRAIN STEM. Clinical manifestations depend on the nature of injury. Diffuse trauma to the brain is frequently associated with DIFFUSE AXONAL INJURY or COMA, POST-TRAUMATIC. Localized injuries may be associated with NEUROBEHAVIORAL MANIFESTATIONS; HEMIPARESIS, or other focal neurologic deficits.

Traumatic injuries to the cranium where the integrity of the skull is not compromised and no bone fragments or other objects penetrate the skull and dura mater. This frequently results in mechanical injury being transmitted to intracranial structures which may produce traumatic brain injuries, hemorrhage, or cranial nerve injury. (From Rowland, Merritt's Textbook of Neurology, 9th ed, p417)

Bleeding within the brain as a result of penetrating and nonpenetrating CRANIOCEREBRAL TRAUMA. Traumatically induced hemorrhages may occur in any area of the brain, including the CEREBRUM; BRAIN STEM (see BRAIN STEM HEMORRHAGE, TRAUMATIC); and CEREBELLUM.

Bleeding into structures of BRAIN STEM, including the MIDBRAIN; PONS; or MEDULLA OBLONGATA, as the result of CRANIOCEREBRAL TRAUMA. DIFFUSE AXONAL INJURY is commonly associated. Clinical manifestations may include OCULAR MOTILITY DISORDERS; ATAXIA; PARALYSIS; PERSISTENT VEGETATIVE STATE; and COMA.

More From BioPortfolio on "Study of Citicoline for the Treatment of Traumatic Brain Injury (COBRIT)"

Quick Search
Advertisement
 

Relevant Topics

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...

Anxiety Disorders
Anxiety is caused by stress. It is a natural reaction, and is beneficial in helping us deal with tense situations and pressure. It is deterimental when is becomes an excessive, irrational dread of everyday situations. The most common types of anxiety di...

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinsons Sleep Disorders Neurology is the branch of medicine concer...


Searches Linking to this Trial