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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00171795

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Drug: Rivastigmine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2002

Actual Primary Completion Date :

May 1, 2005

Actual Study Completion Date :

May 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

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.