Trial | NCT00219245  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    157
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.
Study Started
Nov 30
2002
Primary Completion
Jan 31
2005
Study Completion
Jan 31
2005
Last Update
Nov 17
2011
Estimate

Drug Rivastigmine

Criteria 

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.
No Results Posted