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

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Lacosamide (LCM)	Lacosamide (200 mg/20 mL)	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).

Primary Outcome Measures

Name	Time	Method
The Total Number of Subject Withdrawal Due to Adverse Events During the Study	During the study (Screening through End of Study (Day -1 through Day 6))	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.
The Total Number of Subjects Experiencing at Least One Adverse Event During the Study	During the study (Screening through End of Study (Day -1 through Day 6))	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.

Secondary Outcome Measures

Name	Time	Method
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
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 5	20 minutes prior infusion at Day 5
Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) 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

Locations (5): 81025
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Sapporo, Japan
81027
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Hamamatsu, Japan
81003
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Shizuoka, Japan
81024
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Kodaira, Japan
81023
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Suita, Japan