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A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures

Primary Purpose

Epilepsy, Partial Onset Seizures

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lacosamide 50 mg
Lacosamide 100 mg
Placebo
Sponsored by
UCB Pharma SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Lacosamide, Epilepsy, Partial Onset Seizures

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has had an Electroencephalogram (EEG) and a brain Computerized Tomography (CT) scan or Magnetic Resonance Imaging (MRI) exam consistent with a Diagnosis of Epilepsy with Partial-Onset Seizures according to the International Classification of Epileptic Seizures (1981)
  • Subject must have been observed to have Partial-Onset Seizures for at least the previous 2 years despite prior therapy with at least 2 Anti-Epileptic Drugs (AEDs)(concurrently or sequentially) and must have been observed to have on average at least 4 Partial-Onset Seizures per 28 days with a seizure-free phase no longer than 21 days in the 8-Week Period prior to entry into the Baseline Period. In the case of Simple Partial Seizures, only those with motor signs will be counted towards meeting the inclusion criterion
  • Subjects must be on a stable dose regimen of at least 1, but no more than 3 AEDs (concurrent stable Vagus Nerve Stimulation (VNS) is not counted as an AED). The VNS must have been in place for at least 6 months prior to study entry. The dosage of concomitant AED therapy and the settings of the VNS must be kept constant for a period of at least 4 weeks prior to entry into the Baseline Period
  • Minimum Body Weight of 40 kg

Exclusion Criteria:

  • Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt) or has a suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
  • Subject has a current or previous diagnosis of Pseudo-Seizures, Conversion Disorders, or other non-epileptical events that could be confused with Seizures
  • Subject has Seizures that are uncountable due to Clustering (ie, an episode lasting less than 30 minutes in which several Seizures occur with such frequency that the initiation and completion of each individual Seizure cannot be distinguished) during the 8-Week Period prior to Visit 1
  • Subject has a history of Primary Generalized Seizures
  • Subject with a history of Status Epilepticus within the 12-Months Period prior to Visit 1
  • Subject who underwent surgery for Epilepsy within the 2 Years Period prior to Visit 1
  • Subjects with cardiac, renal, hepatic, endocrinological dysfunction or psychiatric illness that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol

Sites / Locations

  • 86026
  • 86027
  • 86015
  • 86005
  • 86032
  • 86006
  • 86031
  • 86009
  • 86007
  • 86008
  • 86013
  • 86016
  • 86014
  • 86010
  • 86019
  • 86004
  • 86011
  • 86012
  • 86028
  • 86003
  • 86001
  • 86023
  • 86025
  • 86021
  • 86020
  • 86022
  • 86002
  • 86018
  • 86024
  • 86017
  • 86029
  • 81056
  • 81030
  • 81013
  • 81054
  • 81057
  • 81008
  • 81027
  • 81004
  • 81018
  • 81019
  • 81012
  • 81033
  • 81017
  • 81024
  • 81010
  • 81032
  • 81014
  • 81047
  • 81035
  • 81028
  • 81029
  • 81040
  • 81007
  • 81002
  • 81046
  • 81005
  • 81009
  • 81011
  • 81042
  • 81025
  • 81048
  • 81053
  • 81020
  • 81031
  • 81021
  • 81022
  • 81026
  • 81003
  • 81023
  • 81051
  • 81052
  • 81016
  • 81006
  • 81050
  • 81001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Lacosamide 200 mg/day

Lacosamide 400 mg/day

Arm Description

Matching placebo for 16 weeks.

Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks.

Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.

Outcomes

Primary Outcome Measures

Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period
Partial-onset seizure (POS) frequency per 28 days was calculated as: POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28. A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period.

Secondary Outcome Measures

The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)
Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period
Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.
Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)
Partial-onset seizure (POS) frequency per 28 days was calculated as: POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28. A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period.

Full Information

First Posted
October 17, 2012
Last Updated
July 28, 2017
Sponsor
UCB Pharma SA
Collaborators
UCB Japan Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01710657
Brief Title
A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures
Official Title
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Uncontrolled 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
September 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma SA
Collaborators
UCB Japan Co. Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary generalization.

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, Epilepsy, Partial Onset Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
548 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo for 16 weeks.
Arm Title
Lacosamide 200 mg/day
Arm Type
Experimental
Arm Description
Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks.
Arm Title
Lacosamide 400 mg/day
Arm Type
Experimental
Arm Description
Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Lacosamide 50 mg
Other Intervention Name(s)
Vimpat
Intervention Description
Active Substance: Lacosamide Pharmaceutical Form: Film-coated tablet Concentration: 50 mg Route of Administration: Oral use
Intervention Type
Drug
Intervention Name(s)
Lacosamide 100 mg
Other Intervention Name(s)
Vimpat
Intervention Description
Active Substance: Lacosamide Pharmaceutical Form: Film-coated tablet Concentration: 100 mg Route of Administration: Oral use
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching oral Placebo tablets twice daily for 16 weeks.
Primary Outcome Measure Information:
Title
Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period
Description
Partial-onset seizure (POS) frequency per 28 days was calculated as: POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28. A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period.
Time Frame
8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)
Secondary Outcome Measure Information:
Title
The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)
Time Frame
8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)
Title
Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period
Description
Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.
Time Frame
8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)
Title
Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)
Description
Partial-onset seizure (POS) frequency per 28 days was calculated as: POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28. A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period.
Time Frame
8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has had an Electroencephalogram (EEG) and a brain Computerized Tomography (CT) scan or Magnetic Resonance Imaging (MRI) exam consistent with a Diagnosis of Epilepsy with Partial-Onset Seizures according to the International Classification of Epileptic Seizures (1981) Subject must have been observed to have Partial-Onset Seizures for at least the previous 2 years despite prior therapy with at least 2 Anti-Epileptic Drugs (AEDs)(concurrently or sequentially) and must have been observed to have on average at least 4 Partial-Onset Seizures per 28 days with a seizure-free phase no longer than 21 days in the 8-Week Period prior to entry into the Baseline Period. In the case of Simple Partial Seizures, only those with motor signs will be counted towards meeting the inclusion criterion Subjects must be on a stable dose regimen of at least 1, but no more than 3 AEDs (concurrent stable Vagus Nerve Stimulation (VNS) is not counted as an AED). The VNS must have been in place for at least 6 months prior to study entry. The dosage of concomitant AED therapy and the settings of the VNS must be kept constant for a period of at least 4 weeks prior to entry into the Baseline Period Minimum Body Weight of 40 kg Exclusion Criteria: Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt) or has a suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening Subject has a current or previous diagnosis of Pseudo-Seizures, Conversion Disorders, or other non-epileptical events that could be confused with Seizures Subject has Seizures that are uncountable due to Clustering (ie, an episode lasting less than 30 minutes in which several Seizures occur with such frequency that the initiation and completion of each individual Seizure cannot be distinguished) during the 8-Week Period prior to Visit 1 Subject has a history of Primary Generalized Seizures Subject with a history of Status Epilepticus within the 12-Months Period prior to Visit 1 Subject who underwent surgery for Epilepsy within the 2 Years Period prior to Visit 1 Subjects with cardiac, renal, hepatic, endocrinological dysfunction or psychiatric illness that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
86026
City
Beijing
Country
China
Facility Name
86027
City
Beijing
Country
China
Facility Name
86015
City
Changchun
Country
China
Facility Name
86005
City
Chengdu
Country
China
Facility Name
86032
City
Chengdu
Country
China
Facility Name
86006
City
Chongqing
Country
China
Facility Name
86031
City
Dalian
Country
China
Facility Name
86009
City
Guanghzou
Country
China
Facility Name
86007
City
Guangzhou
Country
China
Facility Name
86008
City
Guangzhou
Country
China
Facility Name
86013
City
Guangzhou
Country
China
Facility Name
86016
City
Guangzhou
Country
China
Facility Name
86014
City
Hangzhou
Country
China
Facility Name
86010
City
Harbin
Country
China
Facility Name
86019
City
Jinan
Country
China
Facility Name
86004
City
Kunming
Country
China
Facility Name
86011
City
Nanchang
Country
China
Facility Name
86012
City
Nanchang
Country
China
Facility Name
86028
City
Nanjing
Country
China
Facility Name
86003
City
Qingdao
Country
China
Facility Name
86001
City
Shanghai
Country
China
Facility Name
86023
City
Shanghai
Country
China
Facility Name
86025
City
Shanghai
Country
China
Facility Name
86021
City
Shenyang
Country
China
Facility Name
86020
City
Shijiazhuang
Country
China
Facility Name
86022
City
Suzhou
Country
China
Facility Name
86002
City
Taiyuan
Country
China
Facility Name
86018
City
Wuhan
Country
China
Facility Name
86024
City
Wuhan
Country
China
Facility Name
86017
City
Xi'An
Country
China
Facility Name
86029
City
Xiamen
Country
China
Facility Name
81056
City
Asaka
Country
Japan
Facility Name
81030
City
Fujisawa
Country
Japan
Facility Name
81013
City
Fukuoka
Country
Japan
Facility Name
81054
City
Fukuoka
Country
Japan
Facility Name
81057
City
Hachinohe
Country
Japan
Facility Name
81008
City
Hakodate
Country
Japan
Facility Name
81027
City
Hamamatsu
Country
Japan
Facility Name
81004
City
Himeji
Country
Japan
Facility Name
81018
City
Hiroshima
Country
Japan
Facility Name
81019
City
Iwanuma
Country
Japan
Facility Name
81012
City
Kagoshima
Country
Japan
Facility Name
81033
City
Kitakyusyu
Country
Japan
Facility Name
81017
City
Kobe
Country
Japan
Facility Name
81024
City
Kodaira
Country
Japan
Facility Name
81010
City
Kokubunji
Country
Japan
Facility Name
81032
City
Koushi
Country
Japan
Facility Name
81014
City
Kurume
Country
Japan
Facility Name
81047
City
Kyoto
Country
Japan
Facility Name
81035
City
Nagakute
Country
Japan
Facility Name
81028
City
Nagoya
Country
Japan
Facility Name
81029
City
Nagoya
Country
Japan
Facility Name
81040
City
Nara
Country
Japan
Facility Name
81007
City
Neyagawa
Country
Japan
Facility Name
81002
City
Niigata
Country
Japan
Facility Name
81046
City
Ohmura
Country
Japan
Facility Name
81005
City
Okayama
Country
Japan
Facility Name
81009
City
Osakasayama
Country
Japan
Facility Name
81011
City
Saitama
Country
Japan
Facility Name
81042
City
Sakai
Country
Japan
Facility Name
81025
City
Sapporo
Country
Japan
Facility Name
81048
City
Sapporo
Country
Japan
Facility Name
81053
City
Sapporo
Country
Japan
Facility Name
81020
City
Sendai
Country
Japan
Facility Name
81031
City
Sendai
Country
Japan
Facility Name
81021
City
Shimotsuke
Country
Japan
Facility Name
81022
City
Shimotsuke
Country
Japan
Facility Name
81026
City
Shinjuku
Country
Japan
Facility Name
81003
City
Shizuoka
Country
Japan
Facility Name
81023
City
Suita
Country
Japan
Facility Name
81051
City
Suita
Country
Japan
Facility Name
81052
City
Suita
Country
Japan
Facility Name
81016
City
Takatsuki
Country
Japan
Facility Name
81006
City
Toyonaka
Country
Japan
Facility Name
81050
City
Ube
Country
Japan
Facility Name
81001
City
Yamagata
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
23859801
Citation
Doty P, Hebert D, Mathy FX, Byrnes W, Zackheim J, Simontacchi K. Development of lacosamide for the treatment of partial-onset seizures. Ann N Y Acad Sci. 2013 Jul;1291(1):56-68. doi: 10.1111/nyas.12213.
Results Reference
result
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures

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