Status:
COMPLETED
Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment
Lead Sponsor:
Novartis
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with traumatic brain injury and cognitive impairment.
Eligibility Criteria
Inclusion
- Traumatic brain injury confirmed by available brain imaging (CT or MRI) and be at least 52 weeks post injury
- Neuropsychologic disturbances indicated by: impaired memory (reduction of below 1 standard deviation (SD) of the mean on the California Verbal Learning Test (CVLT) and impaired executive function (reduction of below 1 standard deviation (SD) of the mean on the Verbal Memory Learning Test (VLMT) and Tower of London Test (ToL) and impaired attention (reduction of below 1 standard deviation (SD) of the mean on the Test Battery for Attentional Performance (TAP)
- Be required to have had sufficient education to read, write, and effectively communicate
- Be cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver according to the investigator's judgement
Exclusion
- A current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances
- A current diagnosis of active, uncontrolled seizure disorder or major depression, or any other diagnosis that may interfere with the patient's response to study medication
- An advanced, severe or unstable disease of any type that may interfere with efficacy evaluations
- Female patients with child-bearing potential who are breast-feeding, pregnant or not practicing non-hormonal contraception
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00171795
Start Date
November 1 2002
End Date
May 1 2005
Last Update
November 23 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.