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VX-765

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

VX-765 · 2 trials · 2 indications

Phase 2 2
NCT01048255Study of VX-765 in Subjects With Treatment-resistant Partial EpilepsyPartial Epilepsy
COMPLETED60 Analytics
NCT00205465Phase 2 Clinical Study in Psoriasis With Oral Investigational Drug VX-765Psoriasis
COMPLETED64 Analytics
PHASE2COMPLETED
Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy
Partial EpilepsyUnlock trial analytics
PHASE2COMPLETED
Phase 2 Clinical Study in Psoriasis With Oral Investigational Drug VX-765
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events)
18 weeks
Incidence of adverse events
Abnormal laboratory values
Abnormal ECGs and vital signs

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 to 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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Frequently asked questions about VX-765

What is VX-765?

VX-765 is an investigational small molecule being developed by Vertex Pharmaceuticals (VRTX) for partial epilepsy and psoriasis. It is in Phase 2 clinical development. VX-765 has been studied in completed Phase 2 trials for both conditions, but it is not approved and remains investigational.

What is VX-765 used for?

VX-765 is being studied for use in partial epilepsy and psoriasis. In partial epilepsy, it was evaluated in patients with treatment-resistant disease. In psoriasis, it was studied as an oral investigational drug. Both indications are in Phase 2 clinical development.

Who makes VX-765?

VX-765 is being developed by Vertex Pharmaceuticals Incorporated, which trades on the stock exchange under the ticker VRTX. Vertex is the developer of this investigational small molecule for partial epilepsy and psoriasis.

What phase is VX-765 in?

VX-765 is in Phase 2 clinical development. It has completed Phase 2 trials for both partial epilepsy and psoriasis. VX-765 is not FDA approved and remains an investigational drug in clinical development.

What clinical trials is VX-765 in?

VX-765 has been studied in two completed Phase 2 trials. NCT00205465 evaluated VX-765 in 64 patients with psoriasis. NCT01048255 studied VX-765 in 60 patients with treatment-resistant partial epilepsy in the United States. Both trials are completed.

Is VX-765 the same as any other drug?

VX-765 is not known to have alternative names. It is an investigational small molecule developed by Vertex Pharmaceuticals for partial epilepsy and psoriasis. No other names for VX-765 have been reported.