An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy
|ClinicalTrials.gov Identifier: NCT01682681|
Recruitment Status : Completed
First Posted : September 11, 2012
Results First Posted : August 16, 2013
Last Update Posted : September 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Topiramate||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||1234 participants|
|Official Title:||A Prospective, Observational, Multi-center Study to Assess Long-term Retention Rate of Topiramate in Patients With Epilepsy|
|Study Start Date :||July 2007|
|Primary Completion Date :||May 2009|
|Study Completion Date :||May 2009|
This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.
- Percentage of Participants Retained to Topiramate Treatment [ Time Frame: Week 52 ]Participants with long term retention of topiramate until 52 weeks were reported
- Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs) [ Time Frame: Baseline up to Week 52 ]Number of participants who received concomitant AEDs along with the topiramate were reported.
- Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy [ Time Frame: Baseline up to Week 52 ]Number of participants who received topiramate as first mono-therapy (initial treatment of epilepsy with a single drug), second mono-therapy (second line treatment with a single drug) or add-on therapy (as a supplement therapy to another drug) were reported.
- Percentage of Participants Without Seizure [ Time Frame: Baseline up to Week 52 ]Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52.
- Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More [ Time Frame: Week 52 ]Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682681
|Study Director:||Janssen Korea, Ltd., Korea Clinical Trial||Janssen Korea, Ltd., Korea|