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

Condition(s) targeted: Traumatic Brain Injury

Intervention: Rivastigmine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharma, Study Director, Affiliation: Novartis

This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo 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

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

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

Secondary outcome:

Safety of rivastigmine

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): 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.

Starting date: November 2002
Ending date: May 2005
Last updated: November 19, 2007