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Tracking Information | |||||
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First Received Date † | September 13, 2005 | ||||
Last Updated Date | November 19, 2007 | ||||
Start Date † | November 2002 | ||||
Current Primary Outcome Measures † |
20 week's treatment with rivastigmine on selective attention compared with placebo in patients with TBI and cognitive impairment | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00171795 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment | ||||
Official Title † | Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment | ||||
Brief Summary | This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with traumatic brain injury and cognitive impairment. |
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Detailed Description | |||||
Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Traumatic Brain Injury | ||||
Intervention † | Drug: Rivastigmine | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 60 | ||||
Completion Date | May 2005 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply. |
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Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | |||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00171795 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Novartis | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Novartis | ||||
Verification Date | November 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |