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

Phase 4

Completed

• Conditions: Traumatic Brain Injury With Persistent Cognitive Deficits

• Registration Number: NCT00219245
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-16
• Last Update Posted: 2011-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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