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Topiramate; Carbamazepine; Valproate

Phase 3

Epilepsy | Small molecule | Neurology |Johnson & Johnson|Last Updated: Jun 8, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment865

FDA Designations

No designations recorded

Clinical trial landscape

Topiramate; Carbamazepine; Valproate · 1 trial · 2 indications

Phase 3 1
NCT00236717A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With EpilepsyEpilepsy
COMPLETED865 Analytics
PHASE3COMPLETED
A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy
Epilepsy
NCT00236717865
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Study Endpoints

Primary Endpoints

Time to first seizure from Day 15 of the study

Secondary Endpoints

Time to first seizure from Day 1 of the study; time to exit from the study; proportion of seizure-free patients during the last 6 months of the double-blind period; safety evaluations conducted throughout the study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Topiramate; Carbamazepine; ValproateDRUG -
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Eligibility Criteria

Age Range6 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Body weight of at least 30 kilograms * New epilepsy diagnosis and at least one unprovoked seizure within 3 months before study entry * No history of antiepileptic drug use or taking a single antiepileptic drug for no longer than 6 weeks * Females must be sexually abstinent, su...

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Competitive Landscape -Epilepsy 35 trials

CompanyTickerTrialsLead PhaseDrugs
Xenon Pharmaceuticals Inc.XENE4PHASE3XEN1101
Praxis Precision Medicines, Inc.PRAX5PHASE3Undisclosed
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
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