drugset / Trial / NCT03108729

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

NCT03108729 ↗

Phase 3 Withdrawn Sumitomo Pharma America, Inc.
NaSingle-groupOpen-labelTreatment

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)

Timeline

Start
2017-07-06
Primary completion
2017-10-26
Completion
2017-10-26

Outcome

Outcome not reported

Stopped: “The study was not withdrawn for safety reasons. The sponsor received approval for the treatment of partial-onset seizures in patients 4 years of age and older”

Drugs

EvaluationDrugModalityDoseRoute
Subject Eslicarbazepine acetate Unknown 300 mg —
Subject Eslicarbazepine acetate Unknown 1600 mg —

Indications