First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients (TEAMS)
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|ClinicalTrials.gov Identifier: NCT01627860|
Recruitment Status : Completed
First Posted : June 26, 2012
Results First Posted : May 24, 2013
Last Update Posted : October 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Topiramate add-on therapy Drug: Topiramate monotherapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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 ]
- 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.
- Dosage Administration of Topamax During Month 4 [ Time Frame: Month 4 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01627860
|Study Director:||Janssen-Cilag Taiwan Clinical Trial||Janssen-Cilag Taiwan|