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

NCT ID: NCT01627860

Last Updated: 2013-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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This is a multicenter, randomized (treatment is assigned by chance), open-label (everyone who is involved in the trial knows the study drug), parallel group trial. The study has three phases: a retrospective baseline assessment of patients (4 weeks), titration period (8 weeks) and maintenance period (8 weeks). After qualifying for trial entry in the retrospective baseline phase, eligible patients will be randomized in 1:1 ratio to receive either topiramate add-on therapy or topiramate monotherapy. During the titration period (period in which the dose of the study drug is increased or decreased at the discretion of investigator), topiramate, given as morning doses, will be started with daily doses of 25 mg/day for one week. After that, topiramate will be given as morning and evening doses, and the doses will be gradually increased every week to reach the initial target dose of 200 mg/day at the end of titration period. During the maintenance period, the dose of topiramate could be increased or decreased according to the investigator's judgment. Patients should keep seizure diaries during the 16 weeks of topiramate treated period and are followed with once monthly visits to the clinic, at which safety will be evaluated.

Conditions

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Epilepsy

Keywords

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Epilepsy Topiramate Neuro-surgical patients Nervous disorder Seizures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topiramate add-on therapy

Group Type ACTIVE_COMPARATOR

Topiramate add-on therapy

Intervention Type DRUG

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

Topiramate monotherapy

Group Type EXPERIMENTAL

Topiramate monotherapy

Intervention Type DRUG

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

Interventions

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Topiramate add-on therapy

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

Intervention Type DRUG

Topiramate monotherapy

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must be diagnosed with seizure disorder
* Have been receiving concomitant therapy with one antiepileptic drug (AED), at stable dose prior to trial entry
* Must be dissatisfied with the current treatment

Exclusion Criteria

* Have treatable cause of seizures (eg, metabolic disturbance, toxic exposure, an active infection, or neoplasm)
* Have grade IV astrocytomas, eg, Glioblastoma multiforme (GBM) or metastases with progression
* Have seizures occurring only in clustered patterns defined as numerous seizures occurring in less than 30 min
* Have had history (within past six months) of a psychiatric or mood disorder requiring electroconvulsive therapy, major tranquilizers, or monoamine oxidase inhibitors
* Have had schizophrenic or history of exhibiting psychotic symptomatology
* Inability to take medication or maintain a seizure calendar, independently or with assistance
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Taiwan Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag Taiwan Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Taiwan

Other Identifiers

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TOPMATEPY4061

Identifier Type: OTHER

Identifier Source: secondary_id

TOP-TWN-MA4

Identifier Type: OTHER

Identifier Source: secondary_id

CR017248

Identifier Type: -

Identifier Source: org_study_id