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OpenTrials
Completed

NCT Number: NCT00219245

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

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.

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Key information

Conditions

Traumatic Brain Injury With Persistent Cognitive Deficits Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cognition Disorders Craniocerebral Trauma Mental Disorders Nervous System Diseases Neurocognitive Disorders Trauma, Nervous System Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rivastigmine

Drug

Primary outcomes

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

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

Secondary outcomes

  1. Changes in cognitive functioning from baseline to week 26

  2. Changes in behavior from baseline to week 26

  3. Changes in depression from baseline to week 26

  4. Changes in quality of life from baseline to week 26

  5. Changes in overall functioning from baseline to week 26

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
Nov 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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