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Rivastigmine

Phase 3

Traumatic Brain Injury | Small molecule | Other |Novartis AG|Last Updated: Nov 23, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment67
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00171795Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive ImpairmentPHASE3 COMPLETED 67Nov 1, 2002May 1, 2005Nov 23, 2011 -
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Study Endpoints
Primary Endpoints
20 week's treatment with rivastigmine on selective attention compared with placebo in patients with TBI and cognitive impairment
Secondary Endpoints
Safety of rivastigmine
Change from baseline to week 20 in cognitive functioning including selective attention, memory, executive function, and global clinical rating
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
RivastigmineDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Traumatic brain injury confirmed by available brain imaging (CT or MRI) and be at least 52 weeks post injury * Neuropsychologic disturbances indicated by: impaired memory (reduction of below 1 standard deviation (SD) of the mean on the California Verbal Learning Test (CVLT) an...

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