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

Overview

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.

Full Title of Study: “A 26-Week Open-Label Extension to Protocol No. CENA713BUS11: A 12-Week, Prospective, Double-blind, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Rivastigmine 3 to 6 mg/Day in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2005

Interventions

  • Drug: Rivastigmine

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Criteria:

  • 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Sponsor GmbH

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