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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219245

Enrollment

157

Registered

2005-09-22

Start date

2002-11-30

Completion date

2005-01-31

Last updated

2011-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury With Persistent Cognitive Deficits

Keywords

Traumatic brain injury, head trauma, rivastigmine, cognitive deficits

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.

Interventions

DRUGRivastigmine

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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.

Design outcomes

Primary

Measure	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

Measure	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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026