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

September 14, 2005
November 16, 2011
November 2002
January 2005   (final data collection date for primary outcome measure)
  • 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
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Complete list of historical versions of study NCT00219245 on ClinicalTrials.gov Archive Site
  • 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
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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
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Traumatic Brain Injury With Persistent Cognitive Deficits
Drug: Rivastigmine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
157
January 2005
January 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00219245
CENA713BUS11E1
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Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Sponsor GmbH
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP