Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
NCT ID: NCT01832038
Last Updated: 2021-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
473 participants
INTERVENTIONAL
2013-03-26
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lacosamide
Lacosamide treatment of 100 - 400 mg/day for long-term
Lacosamide
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.
Interventions
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Lacosamide
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
70 Years
ALL
No
Sponsors
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UCB Japan Co. Ltd.
INDUSTRY
UCB Pharma SA
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273 (UCB)
Locations
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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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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EP0009
Identifier Type: -
Identifier Source: org_study_id
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