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An Extension Study Evaluating the Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00219245
First Posted: September 22, 2005
Last Update Posted: November 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  Purpose
Patients who completed the 12-week double blind protocol may enter this 26-week, open-label extension. This extension will give patients who complete the study an opportunity to receive treatment with open-label rivastigmine 3-12 mg/day and further evaluation for the cognitive deficits related to traumatic brain injury. This extension will enable further evaluation of patients, as well as analyses to be conducted examining response to treatments in the original drug and placebo groups.

Condition Intervention Phase
Traumatic Brain Injury With Persistent Cognitive Deficits Drug: Rivastigmine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A 26-Week Open-Label Extension to Protocol No. CENA713BUS11: A 12-Week, Prospective, Double-blind, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Rivastigmine 3 to 6 mg/Day in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Improvement in cognitive functioning in the areas of attention or verbal memory from baseline to week 26
  • Safety and tolerability of 26 week's of treatment with rivastigmine in patients with traumatic brain injury with persistent cognitive impairment

Secondary Outcome Measures:
  • Changes in cognitive functioning from baseline to week 26
  • Changes in behavior from baseline to week 26
  • Changes in depression from baseline to week 26
  • Changes in quality of life from baseline to week 26
  • Changes in overall functioning from baseline to week 26

Enrollment: 157
Study Start Date: November 2002
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a deficit in the areas of attention and/or memory.
  • Have current cognitive deficits which were present from the time of the injury, are persistent, and are deemed to be the result of the brain injury;
  • Be at least 12 months post brain injury;

Exclusion Criteria:

  • A history of a major brain surgery;
  • A penetrating brain injury (e.g., gun shot wound);
  • A current diagnosis of epilepsy;
  • Had more than one seizure in the past year (patients who have had a single seizure within a year post-injury will be considered on a case by case basis);
  • Previous exposure to rivastigmine.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219245


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Sponsor GmbH
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00219245     History of Changes
Other Study ID Numbers: CENA713BUS11E1
First Submitted: September 14, 2005
First Posted: September 22, 2005
Last Update Posted: November 17, 2011
Last Verified: November 2011

Keywords provided by Novartis:
Traumatic brain injury, head trauma, rivastigmine, cognitive deficits

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Cognition Disorders
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Neurocognitive Disorders
Mental Disorders
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents