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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier:
NCT01627860
First received: May 31, 2012
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Epilepsy
Drug: Topiramate add-on therapy
Drug: Topiramate monotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Topiramate in the Treatment of Epilepsy: 1st Add-on vs. Mono-therapy Study in Neuro-Surgical Patients

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Taiwan Ltd:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Dosage Administration of Topamax During Month 4 [ Time Frame: Month 4 ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: February 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627860

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

No publications provided

Responsible Party: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT01627860     History of Changes
Other Study ID Numbers: CR017248, TOPMATEPY4061, TOP-TWN-MA4
Study First Received: May 31, 2012
Results First Received: September 6, 2012
Last Updated: September 24, 2013
Health Authority: Taiwan : Food and Drug Administration

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

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on July 23, 2014