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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:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00219245
First received: September 14, 2005
Last updated: November 16, 2011
Last verified: November 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219245

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00219245     History of Changes
Other Study ID Numbers: CENA713BUS11E1
Study First Received: September 14, 2005
Last Updated: November 16, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 21, 2013