Clinical trial NCT01710657: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Partial Onset Seizures
Keywords: Lacosamide
Epilepsy
Partial Onset Seizures
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: UCB Japan Co. Ltd.
First posted: 2012-10-19
Enrollment: 548
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period
timeFrame: 8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)
Secondary outcomes:
measure: The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)
timeFrame: 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)
measure: Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period
timeFrame: 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)
measure: Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)
timeFrame: 8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8)
Other outcomes:
Locations:
city: Beijing
country: China
facility: 86026
city: Beijing
country: China
facility: 86027
city: Changchun
country: China
facility: 86015
city: Chengdu
country: China
facility: 86005
city: Chengdu
country: China
facility: 86032
city: Chongqing
country: China
facility: 86006
city: Dalian
country: China
facility: 86031
city: Guanghzou
country: China
facility: 86009
city: Guangzhou
country: China
facility: 86007
city: Guangzhou
country: China
facility: 86008
city: Guangzhou
country: China
facility: 86013
city: Guangzhou
country: China
facility: 86016
city: Hangzhou
country: China
facility: 86014
city: Harbin
country: China
facility: 86010
city: Jinan
country: China
facility: 86019
city: Kunming
country: China
facility: 86004
city: Nanchang
country: China
facility: 86011
city: Nanchang
country: China
facility: 86012
city: Nanjing
country: China
facility: 86028
city: Qingdao
country: China
facility: 86003
city: Shanghai
country: China
facility: 86001
city: Shanghai
country: China
facility: 86023
city: Shanghai
country: China
facility: 86025
city: Shenyang
country: China
facility: 86021
city: Shijiazhuang
country: China
facility: 86020
city: Suzhou
country: China
facility: 86022
city: Taiyuan
country: China
facility: 86002
city: Wuhan
country: China
facility: 86018
city: Wuhan
country: China
facility: 86024
city: Xi'An
country: China
facility: 86017
city: Xiamen
country: China
facility: 86029
city: Asaka
country: Japan
facility: 81056
city: Fujisawa
country: Japan
facility: 81030
city: Fukuoka
country: Japan
facility: 81013
city: Fukuoka
country: Japan
facility: 81054
city: Hachinohe
country: Japan
facility: 81057
city: Hakodate
country: Japan
facility: 81008
city: Hamamatsu
country: Japan
facility: 81027
city: Himeji
country: Japan
facility: 81004
city: Hiroshima
country: Japan
facility: 81018
city: Iwanuma
country: Japan
facility: 81019
city: Kagoshima
country: Japan
facility: 81012
city: Kitakyusyu
country: Japan
facility: 81033
city: Kobe
country: Japan
facility: 81017
city: Kodaira
country: Japan
facility: 81024
city: Kokubunji
country: Japan
facility: 81010
city: Koushi
country: Japan
facility: 81032
city: Kurume
country: Japan
facility: 81014
city: Kyoto
country: Japan
facility: 81047
city: Nagakute
country: Japan
facility: 81035
city: Nagoya
country: Japan
facility: 81028
city: Nagoya
country: Japan
facility: 81029
city: Nara
country: Japan
facility: 81040
city: Neyagawa
country: Japan
facility: 81007
city: Niigata
country: Japan
facility: 81002
city: Ohmura
country: Japan
facility: 81046
city: Okayama
country: Japan
facility: 81005
city: Osakasayama
country: Japan
facility: 81009
city: Saitama
country: Japan
facility: 81011
city: Sakai
country: Japan
facility: 81042
city: Sapporo
country: Japan
facility: 81025
city: Sapporo
country: Japan
facility: 81048
city: Sapporo
country: Japan
facility: 81053
city: Sendai
country: Japan
facility: 81020
city: Sendai
country: Japan
facility: 81031
city: Shimotsuke
country: Japan
facility: 81021
city: Shimotsuke
country: Japan
facility: 81022
city: Shinjuku
country: Japan
facility: 81026
city: Shizuoka
country: Japan
facility: 81003
city: Suita
country: Japan
facility: 81023
city: Suita
country: Japan
facility: 81051
city: Suita
country: Japan
facility: 81052
city: Takatsuki
country: Japan
facility: 81016
city: Toyonaka
country: Japan
facility: 81006
city: Ube
country: Japan
facility: 81050
city: Yamagata
country: Japan
facility: 81001
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
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.