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NCT03108729 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: SEP-093-364
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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)

Conditions

Epilepsy

Keywords

epilepsy; Partial-onset seizures; Focal epilepsy; Focal seizures; Partial onset seizures; Pediatric; Partial seizures

Outcome Measures

Primary Outcomes (6)

• Number of subjects with adverse events (AEs).

  Number of subjects with adverse events (AEs).

  From the time the informed consent is signed to the end of the study, assessed up to 2 years

• Percentage of subjects with adverse events (AEs).

  Percentage of subjects with adverse events (AEs).

  From the time the informed consent is signed to the end of the study, assessed up to 2 years

• Number of subjects with serious adverse events (SAEs).

  Number of subjects with serious adverse events (SAEs).

  From the time the informed consent is signed to the end of the study, assessed up to 2 years

• Percentage of subjects with serious adverse events (SAEs).

  Percentage of subjects with serious adverse events (SAEs).

  From the time the informed consent is signed to the end of the study, assessed up to 2 years

• Number of subjects with adverse events (AEs) leading to discontinuation.

  Number of subjects with adverse events (AEs) leading to discontinuation.

  From the time the informed consent is signed to the end of the study, assessed up to 2 years

• Percentage of subjects with adverse events (AEs) leading to discontinuation.

  Percentage of subjects with adverse events (AEs) leading to discontinuation.

  From the time the informed consent is signed to the end of the study, assessed up to 2 years

Study Arms (1)

eslicarbazepine acetate

EXPERIMENTAL

elicarbazepine acetate, once daily flexible dosing

Drug: Eslicarbazepine acetate

Interventions

Eslicarbazepine acetate DRUG

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.

Also known as: Aptiom, ESL, SEP-0002093, BIA 2-093

eslicarbazepine acetate

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• Non-childbearing potential because she is premenarchal (as assessed by physical examination) and \< 7 y; or
• Non-childbearing potential because she is premenarchal (as assessed by physical examination), ≥ 7 y, and has a negative urine pregnancy test at screening; or
• Childbearing potential; has a negative serum pregnancy test at screening and agrees to satisfy one of the following requirements:
• Complete abstinence from intercourse as a component of a habitually abstinent lifestyle; a minimum of 4 weeks prior to administration of the first dose of study drug, throughout the treatment period, and for a minimum of 8 weeks after completion or premature discontinuation from the study drug (abstinence must be part of an established abstinent lifestyle), and agrees to use a double-barrier method if she becomes sexually active; or
• Established use of acceptable methods of contraception; a minimum of 4 weeks prior to administration of the first dose of study drug, throughout the treatment period, and for a minimum of 8 weeks after completion or premature discontinuation from the study drug. Acceptable methods of birth control are those with established failure rates of \< 1%per year and include:

You may not qualify if:

• 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.
• Subject is currently taking more than 3 AEDs or is taking carbamazepine or oxcarbazepine.
• Subject is taking any protocol-prohibited medication within 4 weeks of first ESL dose.
• Subject has any confounding factor such as pseudoseizures or syncope.
• Subject has a known progressive structural CNS lesion(s) or progressive encephalopathy.
• Subject (≥ 6 y) has an active suicidal plan or intent (in the Investigator's opinion) in the past 4 weeks prior to screening.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (1)

Child Neurology Specialists / Clinical Research Center of Nevada, LLC

Henderson, Nevada, 89052, United States

Location

MeSH Terms

Conditions

Epilepsy; Epilepsies, Partial; Seizures

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• CNS Mecdical Director

  Sunovion Pharmacetuicals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 11, 2017
• Study Start: July 6, 2017
• Primary Completion: October 26, 2017
• Study Completion: October 26, 2017
• Last Updated: January 16, 2018

Record last verified: 2018-01

Locations

US (1)