A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures
NCT ID: NCT01710657
Last Updated: 2017-08-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
548 participants
INTERVENTIONAL
2012-09-30
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Matching placebo for 16 weeks.
Placebo
Matching oral Placebo tablets twice daily for 16 weeks.
Lacosamide 200 mg/day
Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks.
Lacosamide 50 mg
* Active Substance: Lacosamide
* Pharmaceutical Form: Film-coated tablet
* Concentration: 50 mg
* Route of Administration: Oral use
Lacosamide 100 mg
* Active Substance: Lacosamide
* Pharmaceutical Form: Film-coated tablet
* Concentration: 100 mg
* Route of Administration: Oral use
Lacosamide 400 mg/day
Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.
Lacosamide 50 mg
* Active Substance: Lacosamide
* Pharmaceutical Form: Film-coated tablet
* Concentration: 50 mg
* Route of Administration: Oral use
Lacosamide 100 mg
* Active Substance: Lacosamide
* Pharmaceutical Form: Film-coated tablet
* Concentration: 100 mg
* Route of Administration: Oral use
Interventions
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Lacosamide 50 mg
* Active Substance: Lacosamide
* Pharmaceutical Form: Film-coated tablet
* Concentration: 50 mg
* Route of Administration: Oral use
Lacosamide 100 mg
* Active Substance: Lacosamide
* Pharmaceutical Form: Film-coated tablet
* Concentration: 100 mg
* Route of Administration: Oral use
Placebo
Matching oral Placebo tablets twice daily for 16 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
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 Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (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
86009
Guanghzou, , China
86007
Guangzhou, , China
86008
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
86021
Shenyang, , 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
81030
Fujisawa, , Japan
81013
Fukuoka, , Japan
81054
Fukuoka, , Japan
81057
Hachinohe, , Japan
81008
Hakodate, , 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
81046
Ohmura, , Japan
81005
Okayama, , Japan
81011
Saitama, , Japan
81042
Sakai, , Japan
81025
Sapporo, , Japan
81048
Sapporo, , Japan
81053
Sapporo, , Japan
81009
Sayama, , Japan
81020
Sendai, , Japan
81031
Sendai, , Japan
81021
Shimotsuke, , Japan
81022
Shimotsuke, , Japan
81026
Shinjuku, , Japan
81003
Shizuoka, , Japan
81023
Suita, , Japan
81051
Suita, , Japan
81052
Suita, , Japan
81016
Takatsuki, , Japan
81006
Toyonaka, , Japan
81050
Ube, , Japan
81001
Yamagata, , Japan
Countries
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References
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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.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2014-003622-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
JapicCTI-121988
Identifier Type: REGISTRY
Identifier Source: secondary_id
EP0008
Identifier Type: -
Identifier Source: org_study_id
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