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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00219245

Collaborator

(none)

157

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury With Persistent Cognitive Deficits	Drug: Rivastigmine	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

157 participants

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

Study Start Date :

Nov 1, 2002

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Jan 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.