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

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”

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.

Intervention(s) in this Clinical Trial

• Drug: Rivastigmine

Primary 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 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Sponsor GmbH  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00219245

Study ID Number: CENA713BUS11E1

ClinicalTrials.gov Identifier: NCT00219245

Health Authority: United States: Food and Drug Administration