Back to resultsOpen-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures
Primary Purpose
Epilepsy, Partial-onset Seizures
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Lacosamide (200 mg/20 mL)
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Lacosamide, LCM, Epilepsy, Partial-onset seizures, iv
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)
Sites / Locations
- 81027
- 81024
- 81025
- 81003
- 81023
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lacosamide (LCM)
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1
Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2
Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5
Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1
Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2
Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5
Full Information
NCT ID
NCT02192814
First Posted
July 11, 2014
Last Updated
July 28, 2017
Sponsor
UCB Japan Co. Ltd.
Collaborators
Parexel
1. Study Identification
Unique Protocol Identification Number
NCT02192814
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Japan Co. Ltd.
Collaborators
Parexel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Partial-onset Seizures
Keywords
Lacosamide, LCM, Epilepsy, Partial-onset seizures, iv
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lacosamide (LCM)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Lacosamide (200 mg/20 mL)
Other Intervention Name(s)
Vimpat
Intervention Description
Active Substance: Lacosamide
Pharmaceutical form: Solution for intravenous (iv) infusion
Concentration: adapted on concentration of oral dose in EP0009
Route of Administration: Drip infusion
Primary Outcome Measure Information:
Title
The Total Number of Subjects Experiencing at Least One Adverse Event During the Study
Description
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.
Time Frame
During the study (Screening through End of Study (Day -1 through Day 6))
Title
The Total Number of Subject Withdrawal Due to Adverse Events During the Study
Description
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.
Time Frame
During the study (Screening through End of Study (Day -1 through Day 6))
Secondary Outcome Measure Information:
Title
Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1
Time Frame
20 minutes prior infusion at Day 1
Title
Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2
Time Frame
20 minutes prior infusion at Day 2
Title
Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5
Time Frame
20 minutes prior infusion at Day 5
Title
Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1
Time Frame
20 minutes prior infusion at Day 1
Title
Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2
Time Frame
20 minutes prior infusion at Day 2
Title
Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5
Time Frame
20 minutes prior infusion at Day 5
Other Pre-specified Outcome Measures:
Title
The Cumulative Partial-onset Seizure Frequency From Day -1 to Day 5
Description
No descriptive statistics have been calculated for this exploratory Outcome Measure.
Time Frame
From Day -1 to Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
1-877-822-9493
Official's Role
Study Director
Facility Information:
Facility Name
81027
City
Hamamatsu
Country
Japan
Facility Name
81024
City
Kodaira
Country
Japan
Facility Name
81025
City
Sapporo
Country
Japan
Facility Name
81003
City
Shizuoka
Country
Japan
Facility Name
81023
City
Suita
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures
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