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First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients

NCT01627860 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2013-10-29

Study results available
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Summary

The purpose of this study is to examine seizure control and tolerability of Topiramate after either transitioning from previous antiepileptic drug (AED) or adding on to previous AED.

Conditions

Interventions

DRUG

Topiramate add-on therapy

Type=range, unit=mg/day, number=25-200, form=tablet, route=oral use.

DRUG

Topiramate monotherapy

Type= range, unit= mg/day, number= 25-200, form= tablet, route= oral use.

Sponsors & Collaborators

  • Johnson & Johnson Taiwan Ltd

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag Taiwan Clinical Trial · Janssen-Cilag Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-01-31
Completion
2011-01-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01627860 on ClinicalTrials.gov