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

Phase 3

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT00171795
• Lead Sponsor: Novartis

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

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-22
• Last Update Posted: 2011-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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