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DIVALPROATE

Phase 3

Bipolar Disorder | Small molecule | Psychiatry |Sanofi|Last Updated: Jan 11, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00271258Safety Study of Sodium Divalproate in Bipolar Disorder in AdolescentsPHASE3 COMPLETED 200Jan 1, 2005Jan 1, 2007Jan 11, 20111 France
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Study Endpoints
Primary Endpoints
clinical examination
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
SODIUM DIVALPROATEDRUG -
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Eligibility Criteria
Age Range13 Years — 18 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Adolescent boys or girls aged 13 to 18 inclusive * Weighing more than 40 kg * Capable of understanding the protocol * Who have given their written consent, as have their parents or legal guardian unless the adolescent has passed his/her 18th birthday * Presenting the diagnosti...

Countries:France
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