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VX-765

Phase 2

Partial Epilepsy | Small molecule | Neurology |Vertex Pharmaceuticals Incorporated|Last Updated: Jan 27, 2014

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 Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01048255Study of VX-765 in Subjects With Treatment-resistant Partial EpilepsyPHASE2 COMPLETED 60 — — Jan 1, 2010Nov 1, 2010Jan 27, 201412 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events)
18 weeks
Secondary Endpoints
Percent reduction in seizure frequency
6 weeks
Percent of subjects with 50% or greater reduction in seizure frequency
6 weeks
Percent of subjects that become seizure free
2 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VX-765EXPERIMENTAL -
Interventions
NameTypeDescription
VX-765DRUG300mg Oral Tablet, 900mg TID
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Subjects that are male or female aged 18 to 64 years (inclusive) with a body mass index between 18 and 35 (kg/m2) * Subjects must have a diagnosis and history of treatment resistant partial onset seizures for which they are taking 1 to 4 concomitant antiepileptic drugs (AED). ...

Countries:United States
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