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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

November 19, 2007

Start Date ^†

November 2002

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00171795 on ClinicalTrials.gov Archive Site

Current 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

Original 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

Descriptive Information

Brief Title ^†

Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment

Official Title ^†

Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Traumatic Brain Injury

Intervention ^†

Drug: Rivastigmine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

May 2005

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00171795

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Director:

Novartis Pharma

Information Provided By

Novartis

Verification Date

November 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.