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

Information source: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Topiramate add-on therapy (Drug); Topiramate monotherapy (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Johnson & Johnson Taiwan Ltd

Official(s) and/or principal investigator(s):
Janssen-Cilag Taiwan Clinical Trial, Study Director, Affiliation: Janssen-Cilag Taiwan


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.

Clinical Details

Official title: Topiramate in the Treatment of Epilepsy: 1st Add-on vs. Mono-therapy Study in Neuro-Surgical Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4).

Secondary outcome:

Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4

Dosage Administration of Topamax During Month 4

Detailed description: 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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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


Locations and Contacts

Additional Information

Starting date: February 2010
Last updated: September 24, 2013

Page last updated: August 23, 2015

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