Clinical trial NCT01832038: Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
Official title: A Multi-center, Open-label, Uncontrolled, Long-term, Extension Study to Evaluate the Safety and Efficacy of Lacosamide as Adjunctive Therapy in Japanese and Chinese 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
Epilepsy
Partial-onset Seizures
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: UCB Japan Co. Ltd.
First posted: 2013-04-15
Enrollment: 473
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the safety and tolerability of long-term administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with Epilepsy who have completed the Treatment and Transition Period of EP0008 \[NCT01710657\]


Eligibility criteria: Inclusion Criteria:

* Subject has completed the Treatment and Transition Period of EP0008 \[NCT01710657\]

Exclusion Criteria:

* Subjects who withdrew from EP0008 \[NCT01710657\]

Primary outcomes:
measure: Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit
timeFrame: From Visit 1 (Week 0) up to approximately Week 323
measure: Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit
timeFrame: From Visit 1 (Week 0) up to approximately Week 323
Secondary outcomes:
measure: Percent Change in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009
timeFrame: From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009
measure: Percentage of Participants With 50 % Response Rate in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009
timeFrame: From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009
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: Guangzhou
country: China
facility: 86007
city: Guangzhou
country: China
facility: 86008
city: Guangzhou
country: China
facility: 86009
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: 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: Fukuoka
country: Japan
facility: 81013
city: Fukuoka
country: Japan
facility: 81054
city: Hachinohe
country: Japan
facility: 81057
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: Kitakyushu
country: Japan
facility: 81033
city: Kobe
country: Japan
facility: 81017
city: Kodaira
country: Japan
facility: 81024
city: Kokubunji
country: Japan
facility: 81010
city: Koshi
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: 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: 81053
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: Toyonaka
country: Japan
facility: 81006
city: Ube
country: Japan
facility: 81050
city: Yamagata
country: Japan
facility: 81001
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Inoue Y, Liao W, Wang X, Du X, Tennigkeit F, Sasamoto H, Osakabe T, Hoshii N, Yuen N, Hong Z. Safety and efficacy of adjunctive lacosamide in Chinese and Japanese adults with epilepsy and focal seizures: A long-term, open-label extension of a randomized, controlled trial. Epilepsy Res. 2021 Oct;176:106705. doi: 10.1016/j.eplepsyres.2021.106705. Epub 2021 Jun 29.