Status:
COMPLETED
A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Epilepsy
Eligibility:
All Genders
2-15 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilep...
Detailed Description
This is a randomized (study medication assigned to participants by chance), open-label, multi-centric (conducted in more than one center) and 2-arm flexible-dose monotherapy study of topiramate compar...
Eligibility Criteria
Inclusion
- Participant with a clinical diagnosis of new-onset or recent-onset epilepsy characterized by partial-onset seizures (POS) (with or without secondary generalization) or primary generalized tonic-clonic seizures (PGTCS) in accordance with criteria of the International League Against Epilepsy. The epilepsy diagnosis must be within the previous 2 years before screening
- Caregivers (parents or legally acceptable representatives) of the participant must be able to accurately maintain the participant take-home record and seizure diary
- At screening, participant must have weight and height values within the 5th to 95th percentile for chronological age (based on standard Child Height and Weight Charts from the Centers for Disease Control \[CDC\])
- Participant must never have been treated for epilepsy (treatment-naïve) or have been treated with no more than 1 standard antiepileptic drug (AED) if temporary or urgent AED use was necessary. Previous AED exposure must not exceed either of the following: 1.)Thirty-one days immediately preceding enrollment, or 2.)A total of 6 months of previous AED exposure in the past if the AED has been discontinued for at least 1 year prior to enrollment
- Parents (or legally acceptable representatives) of the participant must sign an informed consent/permission document, indicating that they understand the purpose of and procedures required for the study and are willing to give permission for their child to participate in the study. Participant 7 years of age and older, capable of understanding the nature of the study, must provide assent for their participation
Exclusion
- Participant has a surgically implanted and functioning vagus nerve stimulator
- Participant has a history of seizures as a result of a correctable medical condition, such as metabolic disturbance, toxic exposure, neoplasm, or active infection within 2 weeks prior to the first day of Screening
- Participant has had uncontrolled seizures while previously taking either topiramate or levetiracetam
- Participant has a history of non-epileptic seizures within 2 weeks prior to the first day of Screening
- Participant has myoclonic or absence seizures
Key Trial Info
Start Date :
October 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT02201251
Start Date
October 6 2014
End Date
April 30 2020
Last Update
April 29 2025
Active Locations (41)
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1
Birmingham, Alabama, United States
2
Los Angeles, California, United States
3
Gulf Breeze, Florida, United States
4
Orlando, Florida, United States