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

Traumatic Brain Injury With Persistent Cognitive Deficits Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219245
• Other study ID #: CENA713BUS11E1
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: November 16, 2011
• Start date: November 2002
• Est. completion date: January 2005

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Brain Injuries
• Cognition Disorders
• Traumatic Brain Injury With Persistent Cognitive Deficits

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	Improvement in cognitive functioning in the areas of attention or verbal memory from baseline to week 26
Primary	Safety and tolerability of 26 week's of treatment with rivastigmine in patients with traumatic brain injury with persistent cognitive impairment
Secondary	Changes in cognitive functioning from baseline to week 26
Secondary	Changes in behavior from baseline to week 26
Secondary	Changes in depression from baseline to week 26
Secondary	Changes in quality of life from baseline to week 26
Secondary	Changes in overall functioning from baseline to week 26