Status:
COMPLETED
An Extension Study Evaluating the Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits
Lead Sponsor:
Novartis
Conditions:
Traumatic Brain Injury With Persistent Cognitive Deficits
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00219245
Start Date
November 1 2002
End Date
January 1 2005
Last Update
November 17 2011
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