Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171795

Purpose

This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with traumatic brain injury and cognitive impairment.

Condition	Intervention	Phase
Traumatic Brain Injury	Drug: Rivastigmine	Phase III

MedlinePlus related topics: Traumatic Brain Injury

Drug Information available for: Rivastigmine SDZ-ENA 713

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment

Further study details as provided by Novartis:

Primary Outcome Measures:

20 week's treatment with rivastigmine on selective attention compared with placebo in patients with TBI and cognitive impairment

Secondary Outcome Measures:

Safety of rivastigmine
Change from baseline to week 20 in cognitive functioning including selective attention, memory, executive function, and global clinical rating

Estimated Enrollment:	60
Study Start Date:	November 2002
Study Completion Date:	May 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Traumatic brain injury confirmed by available brain imaging (CT or MRI) and be at least 52 weeks post injury
Neuropsychologic disturbances indicated by: impaired memory (reduction of below 1 standard deviation (SD) of the mean on the California Verbal Learning Test (CVLT) and impaired executive function (reduction of below 1 standard deviation (SD) of the mean on the Verbal Memory Learning Test (VLMT) and Tower of London Test (ToL) and impaired attention (reduction of below 1 standard deviation (SD) of the mean on the Test Battery for Attentional Performance (TAP)
Be required to have had sufficient education to read, write, and effectively communicate
Be cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver according to the investigator's judgement

Exclusion Criteria:

A current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances
A current diagnosis of active, uncontrolled seizure disorder or major depression, or any other diagnosis that may interfere with the patient's response to study medication
An advanced, severe or unstable disease of any type that may interfere with efficacy evaluations
Female patients with child-bearing potential who are breast-feeding, pregnant or not practicing non-hormonal contraception

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171795

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharma

More Information

Study ID Numbers:	CENA713BDE01
Study First Received:	September 13, 2005
Last Updated:	November 19, 2007
ClinicalTrials.gov Identifier:	NCT00171795
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Traumatic brain injury,
cognitive impairment,
rivastigmine

Study placed in the following topic categories:

Craniocerebral Trauma
Rivastigmine
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Trauma, Nervous System
Brain Diseases

Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Brain Injuries
Dementia
Delirium

Additional relevant MeSH terms:

Cholinesterase Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

Enzyme Inhibitors
Cholinergic Agents
Central Nervous System Agents
Protective Agents
Neuroprotective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009