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

Novartis

Status and phase: Completed; Phase 4

Conditions: Traumatic Brain Injury With Persistent Cognitive Deficits

Treatments: Drug: Rivastigmine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00219245

CENA713BUS11E1

Details and patient eligibility

About

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.

Enrollment: 157 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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.