- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01627860
First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients (TEAMS)
September 24, 2013 updated by: Johnson & Johnson Taiwan Ltd
Topiramate in the Treatment of Epilepsy: 1st Add-on vs. Mono-therapy Study in Neuro-Surgical Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
55
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Topiramate add-on therapy
|
Type=range, unit=mg/day, number=25-200, form=tablet, route=oral use.
|
Experimental: Topiramate monotherapy
|
Type= range, unit= mg/day, number= 25-200, form= tablet, route= oral use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Month 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline (4 weeks retrospective assessment prior to start of titration period) to Month 4
|
Dosage Administration of Topamax During Month 4
Time Frame: Month 4
|
Month 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Janssen-Cilag Taiwan Clinical Trial, Janssen-Cilag Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
May 31, 2012
First Submitted That Met QC Criteria
June 22, 2012
First Posted (Estimate)
June 26, 2012
Study Record Updates
Last Update Posted (Estimate)
October 29, 2013
Last Update Submitted That Met QC Criteria
September 24, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR017248
- TOPMATEPY4061 (Other Identifier: Janssen-Cilag Taiwan)
- TOP-TWN-MA4 (Other Identifier: Janssen-Cilag Taiwan)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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