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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Eslicarbazepine acetate	Eslicarbazepine acetate tablets, taken once daily for 1 year. The daily maintenance dose will be within the range of 300 mg to 1600 mg ESL, and is determined by body weight, clinical response and tolerability.

Timeline

• Start date: 2017-07-06
• Primary completion: 2017-10-26
• Completion: 2017-10-26
• First posted: 2017-04-11
• Last updated: 2018-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study