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

NCT00171795 | Completed Phase 3

• 1 other identifier: CENA713BDE01
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury,; cognitive impairment,; rivastigmine

Outcome Measures

Primary Outcomes (1)

• 20 week's treatment with rivastigmine on selective attention compared with placebo in patients with TBI and cognitive impairment

Secondary Outcomes (2)

• Safety of rivastigmine

• Change from baseline to week 20 in cognitive functioning including selective attention, memory, executive function, and global clinical rating

Interventions

Rivastigmine DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic; Cognitive Dysfunction

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Novartis Pharma

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: November 1, 2002
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: November 23, 2011

Record last verified: 2011-11