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Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment
This study has been completed.
First Received: September 13, 2005   Last Updated: November 19, 2007   History of Changes
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00171795
  Purpose

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 Intervention Phase
Traumatic Brain Injury
Drug: Rivastigmine
Phase III

MedlinePlus related topics: Traumatic Brain Injury
Drug Information available for: Rivastigmine SDZ-ENA 713
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment

Further study details as provided by Novartis:

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

Estimated Enrollment: 60
Study Start Date: November 2002
Study Completion Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171795

Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharma Novartis Pharma
  More Information

No publications provided

Study ID Numbers: CENA713BDE01
Study First Received: September 13, 2005
Last Updated: November 19, 2007
ClinicalTrials.gov Identifier: NCT00171795     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Traumatic brain injury,
cognitive impairment,
rivastigmine

Study placed in the following topic categories:
Craniocerebral Trauma
Neurotransmitter Agents
Rivastigmine
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Trauma, Nervous System
Cholinergic Agents
Brain Diseases
Neuroprotective Agents
Cognition Disorders
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Brain Injuries
Dementia
Delirium

Additional relevant MeSH terms:
Craniocerebral Trauma
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Rivastigmine
Physiological Effects of Drugs
Nervous System Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Enzyme Inhibitors
Trauma, Nervous System
Cholinergic Agents
Brain Diseases
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Cognition Disorders
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Therapeutic Uses
Brain Injuries
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009