Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures

Study Overview
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Brief Summary
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EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will be administered for 5 days as replacement for oral LCM tablets in Japanese adults with partial-onset seizures.

Official Title
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A Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Intravenous Lacosamide as Replacement for Oral Lacosamide in Japanese Adults With Partial-onset Seizures With or Without Secondary Generalization

Conditions
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Epilepsy, Partial-onset Seizures

Intervention / Treatment
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* Drug: Lacosamide (200 mg/20 mL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is Japanese and enrolled in EP0009 (NCT01832038) receiving oral Lacosamide (LCM) for the treatment of partial-onset seizures and has been enrolled for at least 8 weeks Subject has been on a stable twice daily (bid) dosage regimen of LCM 200 mg/ day to 400 mg/ day, for the 2 weeks prior to entry into EP0024 Subject has been receiving no more than 3 concomitant Antiepileptic Drugs (AEDs) at doses that have remained stable for the 2 weeks prior to entry into EP0024 Exclusion Criteria: Subject has a history of any kind of status epilepticus within 12-month period prior to study entry Subject has actual suicidal ideation as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Since Last Visit version of the Columbia-Suicide Severity Rating Scale (C-SSRS)

Ages Eligible for Study
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Minimum Age: 16 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 (LCM)<br>On Day - 1, LCM oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply. During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days. The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day). | Drug: Lacosamide (200 mg/20 mL)<br>* Active Substance: Lacosamide Pharmaceutical form: Solution for intravenous (iv) infusion Concentration: adapted on concentration of oral dose in EP0009 Route of Administration: Drip infusion<br>* Other names: Vimpat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Total Number of Subjects Experiencing at Least One Adverse Event During the Study | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject 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. | During the study (Screening through End of Study (Day -1 through Day 6)) | 
| The Total Number of Subject Withdrawal Due to Adverse Events During the Study | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject 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. | During the study (Screening through End of Study (Day -1 through Day 6)) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1 |  | 20 minutes prior infusion at Day 1 | 
| Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2 |  | 20 minutes prior infusion at Day 2 | 
| Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5 |  | 20 minutes prior infusion at Day 5 | 
| Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1 |  | 20 minutes prior infusion at Day 1 | 
| Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2 |  | 20 minutes prior infusion at Day 2 | 
| Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5 |  | 20 minutes prior infusion at Day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iv, Lacosamide, LCM, Epilepsy, Partial-onset seizures