Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment

Traumatic Brain Injury Clinical Trial

Official title:

Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171795
• Other study ID #: CENA713BDE01
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: November 22, 2011
• Start date: November 2002
• Est. completion date: May 2005

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Cognition Disorders
• Traumatic Brain Injury

Intervention

Drug:
• Rivastigmine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	20 week's treatment with rivastigmine on selective attention compared with placebo in patients with TBI and cognitive impairment
Secondary	Safety of rivastigmine
Secondary	Change from baseline to week 20 in cognitive functioning including selective attention, memory, executive function, and global clinical rating