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Cherry lamotrigine ODT

Phase 1

Mental Disorders | Small molecule | Other |GSK plc|Last Updated: Aug 3, 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
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01607086Compare the Properties and Characteristics of an Investigational Formulation of Lamotrigine With PlaceboPHASE1 COMPLETED 24Jul 11, 2008Jul 18, 2008Aug 3, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Comparison score of flavor and aftertaste between the active and placebo tablets.
1 day
Secondary Endpoints
Comparison score of mouth feel between the active and placebo tablets
1 day
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALTo receive the sequence of investigational products in the order of AB where A is cherry lamotrigine ODT and B is cherry placebo.
Group 2EXPERIMENTALTo receive the sequence of investigational products in the order of BA where A is cherry lamotrigine ODT and B is cherry placebo.
Interventions
NameTypeDescription
Cherry lamotrigine ODTDRUG25mg, taken orally on one study visit
Cherry PlaceboDRUGTaken orally on one study visit
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: * Healthy as judged by the responsible physician or designee. No clinically significant abnormality identified on the medical or laboratory evaluation. A subject with a clinical ...

Countries:United Kingdom
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Competitive Landscape -Mental Health Disorders 11 trials
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