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

Sumitomo Pharma America, Inc.1 site in 1 countryJuly 6, 2017

ConditionsEpilepsy

InterventionsEslicarbazepine acetate

DrugsEslicarbazepine acetate

Overview

Phase: Phase 3
Intervention: Eslicarbazepine acetate
Conditions: Epilepsy
Sponsor: Sumitomo Pharma America, Inc.
Locations: 1
Primary Endpoint: Number of subjects with adverse events (AEs).
Status: Withdrawn
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 6, 2017

End Date

October 26, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sumitomo Pharma America, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is male or female, 4 to \< 18 y at enrollment, and weighs at least 11 kg at Screening and on the first day of ESL dosing.
•The informed consent must be signed by the parent or legal guardian, and, when appropriate and/or required by state or local law, minor subjects must give written informed assent prior to participation in the study. All subjects in the United States (US) must have a parent or legal guardian, sign a Health Insurance Portability and Accountability Act (HIPAA) form.
•Confirmed diagnosis of epilepsy with partial onset seizures as defined in the Classification of Seizures of the International League Against Epilepsy:
•Epilepsy with partial onset seizures with observable motor component, or complex partial seizures, with or without secondary generalization
•Documented EEG recording without generalized epileptiform abnormalities and with demonstrated focal abnormalities (done within 5 years prior to screening)
•Documented magnetic resonance imaging (MRI) scan conducted within 5 years (older scans may be acceptable with consent of Medical Monitor) prior to screening, showing either normal results or static focal abnormalities.
•Documented seizure frequency of at least 6 seizures per month prior to screening as reported by a caregiver and documented in subject's seizure history. Note: Retrospective reporting of seizure frequency does not require diary documentation.
•Stable treatment with 1 to 3 AEDs (excluding carbamazepine and oxcarbazepine) for ≥ 2 weeks prior to screening and at least 4 weeks prior to the first ESL dose. Vagal nerve stimulation (if present) does not count as an AED.
•Subject and/or caregiver are willing and able to complete a daily seizure diary for the duration of the study and comply with study procedures.
•A female subject is eligible to enter and participate in the study if she is of:

Exclusion Criteria

•Subject has had prior exposure to or previously participated in a clinical study with ESL.
•Subject has a history of allergic reaction to oxcarbazepine or carbamazepine, or a history of serious allergic reaction (Stevens Johnson syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms \[DRESS\] or similar) to any AED, or a history of serious allergic reactions to other medications.
•Subject has had an EEG showing generalized discharges.
•Subject has had any of the following seizure types at any time: myoclonic, absence, or atonic.
•Subject has Lennox-Gastaut Syndrome or other secondary generalized epilepsy (including inborn errors of metabolism), or Benign Rolandic Epilepsy.
•Subject has a current diagnosis or a history of psychogenic seizures.
•Subject has current seizures related to an acute medical illness.
•Subject has purely subjective seizures.
•Subject has had status epilepticus while taking any seizure medicine in the 3 years prior to screening.
•Subject should not have had febrile illness ≤ 2 weeks prior to screening.