Clinical trial NCT02192814: Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Partial-onset Seizures
Keywords: Lacosamide
LCM
Epilepsy
Partial-onset seizures
iv
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2014-07-17
Enrollment: 9
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: The Total Number of Subjects Experiencing at Least One Adverse Event During the Study
timeFrame: During the study (Screening through End of Study (Day -1 through Day 6))
measure: The Total Number of Subject Withdrawal Due to Adverse Events During the Study
timeFrame: During the study (Screening through End of Study (Day -1 through Day 6))
Secondary outcomes:
measure: Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1
timeFrame: 20 minutes prior infusion at Day 1
measure: Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2
timeFrame: 20 minutes prior infusion at Day 2
measure: Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5
timeFrame: 20 minutes prior infusion at Day 5
measure: Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1
timeFrame: 20 minutes prior infusion at Day 1
measure: Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2
timeFrame: 20 minutes prior infusion at Day 2
measure: Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5
timeFrame: 20 minutes prior infusion at Day 5
Other outcomes:
measure: The Cumulative Partial-onset Seizure Frequency From Day -1 to Day 5
timeFrame: From Day -1 to Day 5
Locations:
city: Hamamatsu
country: Japan
facility: 81027
city: Kodaira
country: Japan
facility: 81024
city: Sapporo
country: Japan
facility: 81025
city: Shizuoka
country: Japan
facility: 81003
city: Suita
country: Japan
facility: 81023
Study officials:
affiliation: 1-877-822-9493
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: