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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 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Traumatic brain injury, cognitive impairment, rivastigmine |
Craniocerebral Trauma Rivastigmine Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Trauma, Nervous System Brain Diseases |
Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Brain Injuries Dementia Delirium |
Cholinesterase Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Enzyme Inhibitors Cholinergic Agents Central Nervous System Agents Protective Agents Neuroprotective Agents Pharmacologic Actions |