Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
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
1 other identifier
interventional
473
2 countries
67
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 \[NCT01710657\]
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2013
Longer than P75 for phase_3
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 26, 2013
CompletedFirst Submitted
Initial submission to the registry
March 28, 2013
CompletedFirst Posted
Study publicly available on registry
April 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedResults Posted
Study results publicly available
August 13, 2020
CompletedAugust 17, 2021
August 1, 2021
6.4 years
March 28, 2013
July 28, 2020
August 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
From Visit 1 (Week 0) up to approximately Week 323
Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment and led to the withdrawal of the participants from the study. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
From Visit 1 (Week 0) up to approximately Week 323
Secondary Outcomes (2)
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
From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009
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
From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009
Study Arms (1)
Lacosamide
EXPERIMENTALLacosamide treatment of 100 - 400 mg/day for long-term
Interventions
Strength: Lacosamide (LCM) 50 mg, LCM 100 mg Formulation: Tablet Frequency: twice daily during the study period (until the date of approval) At the completion of EP0008 \[NCT01710657\], all subjects who choose to enroll in EP0009 will be taking a dose of Lacosamide 200 mg/day. At the beginning of EP0009, the investigator may maintain the LCM dose or increase or decrease the dose. During the Treatment Period, the investigator will be allowed to increase or decrease the dose of LCM to optimize tolerability and seizure reduction. The LCM dose may be decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day.
Eligibility Criteria
You may qualify if:
- Subject has completed the Treatment and Transition Period of EP0008 \[NCT01710657\]
You may not qualify if:
- Subjects who withdrew from EP0008 \[NCT01710657\]
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharma SAlead
- UCB Japan Co. Ltd.collaborator
Study Sites (67)
86026
Beijing, China
86027
Beijing, China
86015
Changchun, China
86005
Chengdu, China
86032
Chengdu, China
86006
Chongqing, China
86031
Dalian, China
86007
Guangzhou, China
86008
Guangzhou, China
86009
Guangzhou, China
86013
Guangzhou, China
86016
Guangzhou, China
86014
Hangzhou, China
86010
Harbin, China
86019
Jinan, China
86004
Kunming, China
86011
Nanchang, China
86012
Nanchang, China
86028
Nanjing, China
86003
Qingdao, China
86001
Shanghai, China
86023
Shanghai, China
86025
Shanghai, China
86020
Shijiazhuang, China
86022
Suzhou, China
86002
Taiyuan, China
86018
Wuhan, China
86024
Wuhan, China
86017
Xi'an, China
86029
Xiamen, China
81056
Asaka, Japan
81013
Fukuoka, Japan
81054
Fukuoka, Japan
81057
Hachinohe, Japan
81027
Hamamatsu, Japan
81004
Himeji, Japan
81018
Hiroshima, Japan
81019
Iwanuma, Japan
81012
Kagoshima, Japan
81033
Kitakyushu, Japan
81017
Kobe, Japan
81024
Kodaira, Japan
81010
Kokubunji, Japan
81032
Kōshi, Japan
81014
Kurume, Japan
81047
Kyoto, Japan
81035
Nagakute, Japan
81028
Nagoya, Japan
81029
Nagoya, Japan
81040
Nara, Japan
81007
Neyagawa, Japan
81002
Niigata, Japan
81005
Okayama, Japan
81011
Saitama, Japan
81042
Sakai, Japan
81025
Sapporo, Japan
81053
Sapporo, Japan
81009
Sayama, Japan
81021
Shimotsuke, Japan
81022
Shimotsuke, Japan
81026
Shinjuku, Japan
81003
Shizuoka, Japan
81023
Suita, Japan
81051
Suita, Japan
81006
Toyonaka, Japan
81050
Ube, Japan
81001
Yamagata, Japan
Related Publications (1)
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.
PMID: 34246118RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 844 599 2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2013
First Posted
April 15, 2013
Study Start
March 26, 2013
Primary Completion
July 31, 2019
Study Completion
July 31, 2019
Last Updated
August 17, 2021
Results First Posted
August 13, 2020
Record last verified: 2021-08