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USL255

Phase 3

Epilepsy | Small molecule | Neurology |Smith & Nephew SNATS, Inc.|Last Updated: Feb 23, 2015

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment459
FDA Designations
No designations recorded
Clinical trial landscape

USL255 · 2 trials · 1 indication

Phase 3 2
NCT01191086Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset SeizuresEpilepsy
COMPLETED210 Analytics
NCT01142193Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset SeizuresEpilepsy
COMPLETED249 Analytics
PHASE3COMPLETED
Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures
Epilepsy
NCT01191086210
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PHASE3COMPLETED
Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures
Epilepsy
NCT01142193249
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Study Endpoints
Primary Endpoints
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
Open label treatment of up to 62 weeks
Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.
11 weeks
Secondary Endpoints
Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.
11 weeks
Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.
3 weeks (weeks 1-3)
Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.
3 weeks (weeks 1-3)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Open-label USL255EXPERIMENTALTopiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
USL255EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
USL255DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites68

Inclusion Criteria: * Have completed the maintenance period of the P09-004 study. * Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.

Countries:United StatesArgentinaAustraliaBelgiumCanadaChileGermanyGreeceIndiaIsraelNew ZealandPolandRussiaSouth AfricaSpainHungary
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Competitive Landscape -Epilepsy 36 trials
CompanyTickerTrialsLead PhaseDrugs
Xenon Pharmaceuticals Inc.XENE4PHASE3XEN1101
Praxis Precision Medicines, Inc.PRAX6PHASE3vormatrogine
Rapport Therapeutics, Inc.RAPP3PHASE3RAP-219
Supernus Pharmaceuticals, Inc.SUPN4PHASE2SPN-817
Biohaven Ltd.BHVN3PHASE2BHV-7000
Harmony Biosciences Holdings, Inc.HRMY1PHASE3Clemizole
NeuroPace, Inc.NPCE1PHASE2Undisclosed
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE1CBD-OS
Bright Minds Biosciences Inc.DRUG1PHASE2BMB-101
uniQure N.V.QURE1PHASE1AAV9-hSyn1-miGRIK2
Boston Scientific CorporationBSX1N/AUndisclosed
Tango Therapeutics, Inc.TNGX1PHASE1S230815- Starting dose A, S230815- Dose B, S230815- Dose C, S230815- Dose D
IQVIA Holdings IncIQV1 - Undisclosed
NeuroOne Medical Technologies CorporationNMTC1 - Undisclosed
Unity Health TorontoUBX1N/AUndisclosed
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