- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00219245
An Extension Study Evaluating the Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits
November 16, 2011 updated by: Novartis
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
157
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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 Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2002
Primary Completion (Actual)
January 1, 2005
Study Completion (Actual)
January 1, 2005
Study Registration Dates
First Submitted
September 14, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
November 17, 2011
Last Update Submitted That Met QC Criteria
November 16, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Craniocerebral Trauma
- Trauma, Nervous System
- Brain Injuries
- Wounds and Injuries
- Brain Injuries, Traumatic
- Cognitive Dysfunction
- Cognition Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Neuroprotective Agents
- Protective Agents
- Cholinesterase Inhibitors
- Rivastigmine
Other Study ID Numbers
- CENA713BUS11E1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Traumatic Brain Injury With Persistent Cognitive Deficits
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Hamad Medical CorporationRecruiting
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Indiana UniversityRecruitingTraumatic Brain Injury | Concussion, Severe | Concussion, Intermediate | Concussion With Brief Loss of Consciousness | Traumatic Brain Injury With Brief Loss of Consciousness | Traumatic Brain Injury With No Loss of Consciousness | Concussion With LOC 31 to 59 Minutes | Traumatic Brain Injury With... and other conditionsUnited States
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Shirley Ryan AbilityLabUnited States Department of Defense; Edward Hines Jr. VA HospitalCompletedTraumatic Brain Injury | Vestibular DeficitsUnited States
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VA Office of Research and DevelopmentNew York UniversityCompletedMild Traumatic Brain Injury | Persistent Post Traumatic HeadacheUnited States
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BrainCheck, Inc.UnknownCognitive Impairment | Dementia | Mild Cognitive Impairment | Cognitive Decline | Mild Traumatic Brain Injury | Concussion | Cognitive Changes | Acute Changes in Cognition | Acute Head Injury
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University of Texas Southwestern Medical CenterRecruitingMild Cognitive Impairment | Mild Traumatic Brain Injury | Amnestic Mild Cognitive Impairment | Concussion, Brain | Amnestic Mild Cognitive DisorderUnited States
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Uniformed Services University of the Health SciencesUniversity of California, San FranciscoWithdrawnDementia | Mild Cognitive Impairment (MCI) | Traumatic Brain Injury (TBI) | Post-traumatic Stress Disorder (PTSD) | Chronic Traumatic Encephalopathy (CTE)United States
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University Hospital of FerraraCompletedTraumatic Brain Injury | Balance Disorders | Attention DeficitsItaly
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Spaulding Rehabilitation HospitalTerminatedTBI | Motor Impairments | Attention DeficitsUnited States
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