A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.

Official Title
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A Multicenter, Open-label, Long-term Extension Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Pediatric Subjects With Epilepsy With Partial-Onset Seizures

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Lacosamide
* Drug: Lacosamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors Subject has completed the Transition Period of SP0967 [NCT02477839] or SP0969 [NCT01921205] for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy Subject is expected to benefit from participation, in the opinion of the investigator Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator Subject is male or female aged 1 month to ≤17 years Subject has a diagnosis of epilepsy with partial-onset seizures Exclusion Criteria: Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM) Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for SP0967 or SP0969, or is experiencing an ongoing serious adverse event (SAE) For subjects ≥6 years of age, subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1 Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lacosamide<br>In the first week after enrollment into EP0034 subjects will be dosed according to their weight: Lacosamide (LCM) 10 mg/kg/day (oral solution) for subjects weighing <30 kg LCM 6 mg/kg/day (oral solution) for subjects weighing ≥30 kg to <50 kg LCM 300 mg/day (tablets) for subjects weighing ≥50 kg After 1 week the investigator may adjust the LCM dose during the Treatment Period based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets. | Drug: Lacosamide<br>* Pharmaceutical form: oral solution Concentration: 1 mg/kg - 6 mg/kg BID (2 mg/kg/day - 12 mg/ kg/day) Route of administration: oral use<br>* Other names: VIMPAT;Drug: Lacosamide<br>* Pharmaceutical form: tablet Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day) Route of administration: oral use<br>* Other names: VIMPAT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose. | From Week 0 to the End of Safety Follow-Up (up to Week 104) | 
| Percentage of Participants With Serious TEAEs | A serious adverse event (SAE) must meet 1 or more of the following criteria: • Death, • Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), • Significant or persistent disability/incapacity, • Congenital anomaly/birth defect (including that occurring in a fetus), • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious., • Initial inpatient hospitalization or prolongation of hospitalization. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose. | From Week 0 to the End of Safety Follow-Up (up to Week 104) | 
| Percentage of Participants With TEAEs Leading to Study Discontinuation | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to study discontinuation. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose. | From Week 0 to the End of Safety Follow-Up (up to Week 104) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Seizure-free Days During the Study | The number of seizure-free days was the total number of days within an interval for which daily diary data were available and no seizures were reported. The percentage of seizure-free days was computed as 100 times the number of seizure-free days in the interval divided by the number of days in the interval for which daily diary data were available. Percentage of seizure-free days was measured using data obtained from participant diaries from EP0034 and is presented for the overall Treatment only. | From Week 0 to End of Treatment (up to Week 96) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UCB, Lacosamide, Vimpat, Epilepsy, Partial-Onset Seizures, Pediatric