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Licarbazepine

Phase 3

Bipolar I Disorder | Small molecule | Psychiatry |Novartis AG|Last Updated: Mar 28, 2017

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
UNCONTROLLED
Total Trials2
Total Enrollment383
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00228059An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.PHASE3 COMPLETED 132Jan 1, 2005Jul 1, 2007Feb 23, 20171 United States
NCT00238485An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750-2000 mg/d in the Treatment of Manic Episodes of Bipolar I DisorderPHASE3 COMPLETED 251Jan 1, 2005Jul 1, 2007Mar 28, 2017 -
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Study Endpoints
Primary Endpoints
Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
LicarbazepineDRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. written informed consent provided prior to participation in the extension study 2. successful completion of study CLIC477D2301 3. willingness and ability to comply with all study requirements Exclusion Criteria: 1. premature discontinuation from study CLIC477D2301 2. failur...

Countries:United States
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