An Extension Study Evaluating the Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits

NCT00219245 | Completed Phase 4

• 1 other identifier: CENA713BUS11E1
• Study Type: interventional
• Target: 157
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Traumatic Brain Injury With Persistent Cognitive Deficits

Keywords

Traumatic brain injury, head trauma, rivastigmine, cognitive deficits

Outcome Measures

Primary Outcomes (2)

• Improvement in cognitive functioning in the areas of attention or verbal memory from baseline to week 26

• Safety and tolerability of 26 week's of treatment with rivastigmine in patients with traumatic brain injury with persistent cognitive impairment

Secondary Outcomes (5)

• Changes in cognitive functioning from baseline to week 26

• Changes in behavior from baseline to week 26

• Changes in depression from baseline to week 26

• Changes in quality of life from baseline to week 26

• Changes in overall functioning from baseline to week 26

Interventions

Rivastigmine DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic; Craniocerebral Trauma; Cognition Disorders

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Novartis Pharmaceuticals

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2002
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: November 17, 2011

Record last verified: 2011-11