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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00171795 |
This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with traumatic brain injury and cognitive impairment.
Condition | Intervention | Phase |
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Traumatic Brain Injury |
Drug: Rivastigmine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment |
Estimated Enrollment: | 60 |
Study Start Date: | November 2002 |
Study Completion Date: | May 2005 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Study ID Numbers: | CENA713BDE01 |
Study First Received: | September 13, 2005 |
Last Updated: | November 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00171795 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Traumatic brain injury, cognitive impairment, rivastigmine |
Craniocerebral Trauma Neurotransmitter Agents Rivastigmine Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Trauma, Nervous System Cholinergic Agents Brain Diseases |
Neuroprotective Agents Cognition Disorders Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Brain Injuries Dementia Delirium |
Craniocerebral Trauma Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Rivastigmine Physiological Effects of Drugs Nervous System Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Enzyme Inhibitors Trauma, Nervous System Cholinergic Agents |
Brain Diseases Protective Agents Neuroprotective Agents Pharmacologic Actions Cognition Disorders Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Therapeutic Uses Brain Injuries Central Nervous System Agents |