A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment

Study Overview
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Brief Summary
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The purpose of the study is to assess the long-term use of lacosamide oral solution dosed at 2 mg/kg/day to 12 mg/kg/day when administered to pediatric study participants with epilepsy who have completed NCT01964560 (EP0034) or NCT00938912 (SP848).

Official Title
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A Multicenter, Open-Label, Follow-Up Study to Assess the Long-Term Use of Oral Lacosamide in Study Participants Who Completed EP0034 or SP848 and Received Lacosamide Treatment

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Lacosamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is male or female, aged <6 years at the time of signing the Informed Consent Form (ICF) Participant has completed participation in NCT01964560 (EP0034) or NCT00938912 (SP848) Participant is expected to benefit from participation, in the opinion of the Investigator Exclusion Criteria: Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study Participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol Participant is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM) Participant meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for NCT01964560 (EP0034) or NCT00938912 (SP848), or is experiencing an ongoing serious adverse event (SAE) Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 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>Subjects in this arm will receive various single doses of lacosamide | Drug: Lacosamide<br>* Pharmaceutical form: Oral-solution Route of administration: Oral use Subjects will receive lacosamide in a pre-specified sequence during the Treatment Period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (TEAEs) | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | From visit 1 (Week 0) to the end of study visit (up to Week 213) | 
| Withdrawals from study due to TEAEs | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | From visit 1 (Week 0) to the end of study visit (up to Week 213) | 
| Withdrawals from study due to Serious Adverse Event (SAEs) | Results in death Is life-threatening Requires in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect Is an infection that requires treatment parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above | From visit 1 (Week 0) to the end of study visit (up to Week 213) | 
| Modal daily dose during the study | Modal daily dose, defined as most frequently administered dose per mg/kg/day. | From visit 1 (Week 0) to the end of study visit (up to Week 213) | 
| Maximum daily dose during the study | Maximum daily dose, defined as the highest administered dose per mg/kg/day. | From visit 1 (Week 0) to the end of study visit (up to Week 213) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lacosamide, Vimpat, Epilepsy, Pediatric