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Topiramate; Carbamazepine; Valproate

Phase 3

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

Topiramate; Carbamazepine; Valproate development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Oct 2005

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

Topiramate; Carbamazepine; Valproate clinical trials

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
EpilepsyUnlock trial analytics

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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Frequently asked questions about Topiramate; Carbamazepine; Valproate

What is topiramate used for in epilepsy?

Topiramate is an antiepileptic small molecule studied for the treatment of epilepsy and seizures. It has been evaluated as a treatment option for patients newly diagnosed with epilepsy, including a Phase 3 study comparing it with a standard therapy. It is used in epilepsy management alongside other antiepileptic agents such as carbamazepine and valproate.

Who is developing topiramate for epilepsy?

Johnson & Johnson, which trades under the ticker JNJ, is the developer associated with the Phase 3 epilepsy program for topiramate. The company sponsored a study evaluating topiramate compared with a standard therapy in patients newly diagnosed with epilepsy.

What phase is topiramate in for epilepsy?

Topiramate has been studied in Phase 3 clinical development for epilepsy. The program includes one completed Phase 3 trial, and no active trials are currently listed. The completed study was randomized and double blind, enrolling 865 patients aged 6 years and older.

What clinical trials is topiramate in for epilepsy?

The Phase 3 trial for topiramate in epilepsy is NCT00236717, titled A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy. It is completed, enrolled 865 participants, and included patients aged 6 years and older of all sexes.

Is topiramate the same as carbamazepine or valproate?

No. Topiramate, carbamazepine, and valproate are distinct antiepileptic small molecules. They are separate treatments that have been used in epilepsy care, and topiramate has been studied in comparison with a standard therapy in patients newly diagnosed with epilepsy.