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

Phase 4

Completed

• Conditions: Epilepsy
• Interventions: Drug: Topiramate add-on therapy; Drug: Topiramate monotherapy

• Registration Number: NCT01627860
• Lead Sponsor: Johnson & Johnson Taiwan Ltd

Brief 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.

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.

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2012-05-31
• Study First Submitted QC: 2012-06-22
• Study First Posted: 2012-06-26
• Results First Submitted: 2012-09-06
• Results First Submitted QC: 2013-04-16
• Results First Posted: 2013-05-24
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-24
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topiramate add-on therapy	Topiramate add-on therapy	-
Topiramate monotherapy	Topiramate monotherapy	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Dosage Administration of Topamax During Month 4	Month 4
Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4	Baseline (4 weeks retrospective assessment prior to start of titration period) to Month 4	Seizure frequency (seizure count/month) was calculated based on the number of seizure within a month. The mean seizure frequency analyzed by the ANCOVA model at each period.