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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01627860
Recruitment Status : Completed
First Posted : June 26, 2012
Results First Posted : May 24, 2013
Last Update Posted : October 29, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Topiramate add-on therapy Drug: Topiramate monotherapy Phase 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topiramate in the Treatment of Epilepsy: 1st Add-on vs. Mono-therapy Study in Neuro-Surgical Patients
Study Start Date : February 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Topiramate

Arm Intervention/treatment
Active Comparator: Topiramate add-on therapy Drug: Topiramate add-on therapy
Type=range, unit=mg/day, number=25-200, form=tablet, route=oral use.

Experimental: Topiramate monotherapy Drug: Topiramate monotherapy
Type= range, unit= mg/day, number= 25-200, form= tablet, route= oral use.

Primary Outcome Measures :
  1. Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4). [ Time Frame: Month 4 ]

Secondary Outcome Measures :
  1. Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4 [ Time Frame: 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.

  2. Dosage Administration of Topamax During Month 4 [ Time Frame: Month 4 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01627860

Sponsors and Collaborators
Johnson & Johnson Taiwan Ltd
Study Director: Janssen-Cilag Taiwan Clinical Trial Janssen-Cilag Taiwan

Responsible Party: Johnson & Johnson Taiwan Ltd Identifier: NCT01627860     History of Changes
Other Study ID Numbers: CR017248
TOPMATEPY4061 ( Other Identifier: Janssen-Cilag Taiwan )
TOP-TWN-MA4 ( Other Identifier: Janssen-Cilag Taiwan )
First Posted: June 26, 2012    Key Record Dates
Results First Posted: May 24, 2013
Last Update Posted: October 29, 2013
Last Verified: September 2013

Keywords provided by Johnson & Johnson Taiwan Ltd:
Neuro-surgical patients
Nervous disorder

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents