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Radafaxine

Phase 2

Depressive Disorder, Major | Small molecule | Other |GSK plc|Last Updated: Apr 16, 2015

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-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment732
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00057213An 8 Week Study Of Depression In Adults Diagnosed With Major Depressive DisorderPHASE2 COMPLETED 367 — — Mar 1, 2003Apr 1, 2007Apr 16, 201521 United States
NCT00057226An 8 Week Study Of Adults Diagnosed With Major Depressive DisorderPHASE2 COMPLETED 365 — — Mar 1, 2003Apr 1, 2004Apr 16, 201521 United States
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Study Endpoints
Primary Endpoints
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) after 8 weeks of treatment
8 Weeks
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score after 8 weeks of treatment
8 Weeks
Secondary Endpoints
Change in the MADRS score at other timepoints; change in Clinical Global Impression; percentage of remitters and responders based on the MADRS; change in disability, motivation, energy, fatigue and pain;incidence of adverse events over course of study;
Change in the MADRS score at other timepoints; change in the Global Impression; percentage of remitters and responders based on the MADRS; change in anxiety, disability, motivation, energy, fatigue and pain; incidence of adverse events during the study
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
RadafaxineDRUG -
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Diagnosis of Major Depressive Disorder (MDD) * Duration of current depressive episode 12 weeks - 24 months * Patients can read and write at a level sufficient to provide a signed consent * If female, patients must be practicing an acceptable method of birth control Exclusion ...

Countries:United States
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