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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-05-31

Brief Summary

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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

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Conditions

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Traumatic Brain Injury

Keywords

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Traumatic brain injury, cognitive impairment, rivastigmine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Rivastigmine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharma

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

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CENA713BDE01

Identifier Type: -

Identifier Source: org_study_id