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NCT00210782 - A Double-blind Trial Comparing the Efficacy, Tolerability and Safety of Monotherapy Topiramate Versus Phenytoin in Subjects With Seizures Indicative of New Onset Epilepsy

A Double-blind Trial Comparing the Efficacy, Tolerability and Safety of Monotherapy Topiramate Versus Phenytoin in Subjects With Seizures Indicative of New Onset Epilepsy


Data Specification

Not Available


Annotated CRF

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Product Info

Generic Name
Topiramate
Product Name
TOPAMAX®
Therapeutic Area
Nervous System Diseases
Enrollment
262
% Female
51.7%
% White
63.3%
Product Class
Anticonvulsants
Sponsor Protocol Number
CAPSS-272
Data Holder
Johnson & Johnson
Condition Studied
Epilepsy
Mean/Median Age (Years)
34.2

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Collected Datasets
Data Definition Specification
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.