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A Pediatric Drug Study to Determine the Long-term Safety and Tolerability in Children and Adolescents (4-17 Years in Age) Taking the Drug

Epilepsy Clinical Trial

Official title:
An Open-label Eslicarbazepine Acetate Long-term Safety and Tolerability Study in Children and Adolescents (4 - 17 Years)

Clinical Trial Summary

A pediatric drug study to determine the long-term safety and tolerability in children and adolescents (4-17 years in age) taking the drug (elsicarbazepine acetate)

Clinical Trial Description

This is a long-term, multicenter, open-label, safety, tolerability, and maintenance of effect study of flexible daily dosing with Eslicarbazepine acetate (ESL) in subjects 4 to 17 years of age with partial onset seizures (POS). The study is designed to enroll subjects to receive ESL as adjunctive treatment with the option to convert to ESL monotherapy after 6 months of ESL adjunctive treatment. Approximately 150 subjects will be enrolled to obtain approximately 75 subjects completing 1 year of treatment. At least 25% of subjects will be enrolled in each age group (4 - 6, 7 - 11, and 12 - 17 years of age). An attempt will be made to enroll no fewer than 30% of subjects in each gender. It is anticipated that approximately 50 subjects will convert to monotherapy during the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03108729
Study type Interventional
Source Sunovion
Contact
Status Withdrawn
Phase Phase 3
Start date July 6, 2017
Completion date October 26, 2017
View Details
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