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

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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Partial-onset Seizures
• Intervention / Treatment: Drug: Lacosamide (200 mg/20 mL)

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Hamamatsu, Japan
    • 81027
  • Kodaira, Japan
    • 81024
  • Sapporo, Japan
    • 81025
  • Shizuoka, Japan
    • 81003
  • Suita, Japan
    • 81023

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lacosamide (LCM); 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); Active Substance: Lacosamide Pharmaceutical form: Solution for intravenous (iv) infusion Concentration: adapted on concentration of oral dose in EP0009 Route of Administration: Drip infusion; Other Names: Vimpat

What is the study measuring?

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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Cumulative Partial-onset Seizure Frequency From Day -1 to Day 5	No descriptive statistics have been calculated for this exploratory Outcome Measure.	From Day -1 to Day 5

Collaborators and Investigators

• Sponsor: UCB Japan Co. Ltd.
• Collaborators: Parexel

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls
• Product Information

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 17, 2014

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: July 28, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Epilepsy; iv; LCM; Lacosamide; Partial-onset seizures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lacosamide
• Other Study ID Numbers: EP0024 (Other Identifier: JAPIC)