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

1. Subject has had prior exposure to or previously participated in a clinical study with ESL.

2. 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.

3. Subject has had an EEG showing generalized discharges.

4. Subject has had any of the following seizure types at any time: myoclonic, absence, or atonic.

5. Subject has Lennox-Gastaut Syndrome or other secondary generalized epilepsy (including inborn errors of metabolism), or Benign Rolandic Epilepsy.

6. Subject has a current diagnosis or a history of psychogenic seizures.

7. Subject has current seizures related to an acute medical illness.

8. Subject has purely subjective seizures.

9. Subject has had status epilepticus while taking any seizure medicine in the 3 years prior to screening.

10. Subject should not have had febrile illness ≤ 2 weeks prior to screening.

11. Subject is currently taking more than 3 AEDs or is taking carbamazepine or oxcarbazepine.

12. Subject is taking any protocol-prohibited medication within 4 weeks of first ESL dose.

13. Subject has any confounding factor such as pseudoseizures or syncope.

14. Subject has a known progressive structural CNS lesion(s) or progressive encephalopathy.

15. Subject (≥ 6 y) has an active suicidal plan or intent (in the Investigator's opinion) in the past 4 weeks prior to screening.

16. Subject has a history of suicide attempt in the last 2 years prior to screening.

17. Subject is at imminent risk of suicidal or homicidal action (in the Investigator's opinion).

18. Subjects who meet the Diagnostic and Statistical Manual of Mental Disorders, 5th edition text revision (DSM-V-TR) defined criteria for major depressive episode (MDE) within the last 6 months. Subjects with mild, chronic depression without recent hospitalization who are being maintained on a stable dose of a single antidepressant are acceptable.

19. Subject has a significant psychiatric disorder or history of recurrent episodes of severe depression requiring pharmacologic treatment or hospitalization within 2 years prior to screening.

20. Subject has a history of alcohol or substance abuse within 2 years prior to screening for study participation, or subjects currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner, which, in the opinion of the Investigator, indicates abuse. Subjects who are regular users of medical marijuana are excluded; use during participation is prohibited.

21. Subject has a positive urine drug screen (UDS) at screening. Note: Subjects with a positive drug screen for amphetamines, opiates, or benzodiazepines, who have a prescribed medication for at least 4 weeks prior to screening, may be eligible to participate in the study upon approval from the Medical Monitor.

22. Subject has a major medical illness other than epilepsy that would prevent safe participation in this study, at the discretion of the Investigator, such as (but not limited to) chronic liver or kidney impairment.

23. Subject has a disorder or history of a condition that may interfere with drug absorption, distribution, metabolism, or excretion (eg, malabsorption, gastrointestinal surgery, clinically significant abnormality of the hepatic or renal system). Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted.

Subject has a history or presence of abnormal ECG, which in the Investigator's opinion is clinically significant or QTcB of \~ 450 msec per screening central over read ECG.

25\. Subject is known to have tested seropositive for the human immunodeficiency virus (HIV).

26\. Subject has a positive history for the hepatitis B surface antigen or hepatitis C antibody.

27\. Subject has a history of hypothyroidism, hyperthyroidism, or has values for thyroid testing (free T3, free T4, thyroid stimulating hormone \[TSH\]) indicating the presence of significant thyroid dysfunction.

28\. Subjects has the following abnormal laboratory tests (not limited to, but including the following): a. Aspartate aminotransferase (ALT)/alanine aminotransferase (AST) \> 1.5 times the upper limit of normal (ULN) b. White blood cell (WBC) count of \< 2500 cells/μL c. Platelet count of \< 100 × 103 cells/μL

Note: Subjects with stable platelet counts over the last 3 months prior to screening in the range of 80 × 103 to 100 × 103 cells/μL are eligible to participate in the study.

d. Subjects have estimated creatinine clearance by modified Schwartz GFR of 77.8 mL/min/1.73m2.

e. Subject has a sodium level of \< 130 mEq/L.

29\. Subject has difficulty providing blood samples due to poor venous access or cannot safely provide a sufficient quantity of blood.

30\. Subjects of Asian ancestry must not be carriers of HLA b\*1502. Either: a) subjects/caregivers must give written informed consent for genotyping, and test negative, or b) subjects/caregivers must provide documentation of prior testing confirming non carrier status and documented in subject's medical history.

31\. Subject is a female who is currently breastfeeding or intending to breastfeed during the study period, or within 3 months postpartum at the time of signing informed consent.

32\. Subject has participated in any investigational study within 30 days prior to screening, as documented in subject's medical history.

33\. Subject is unable to comply with study visit schedules or study procedures, except those that can be performed by a caregiver.

34\. Subject is a Clinical or Investigational Site staff member or relative of a staff member.

35\. Subject has experienced significant blood loss within 60 days or has donated plasma within 72 hours prior to Visit 1 or intends to donate blood or undergo elective surgery during the study or within 60 days following the study.

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

What this study is about

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

What this study is about