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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Traumatic Brain Injury With Persistent Cognitive Deficits

Intervention / Treatment
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* Drug: Rivastigmine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rivastigmine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic brain injury, head trauma, rivastigmine, cognitive deficits