drugset / Trial / NCT02201251
A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
RandomizedParallel-groupOpen-labelHealth-services research
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 epilepsy (seizure disorder) on pediatric growth and maturation, bone mineralization, and kidney stone formation in children aged 2 to 15 years.
Timeline
- Start
- 2014-10-06
- Primary completion
- 2020-04-30
- Completion
- 2020-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Levetiracetam | Other / unclassified | 60 mg/kg | — |
| Comparator | Levetiracetam | Other / unclassified | 3000 mg | — |
| Subject | Topiramate | Small molecule | 350 mg | — |
| Subject | Topiramate | Small molecule | 400 mg | — |