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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01710657
Other study ID # EP0008
Secondary ID 2014-003622-41Ja
Status Completed
Phase Phase 3
First received October 17, 2012
Last updated March 4, 2015
Start date September 2012
Est. completion date August 2014

Study information

Verified date March 2015
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and WelfareChina: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 548
Est. completion date August 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
China 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
Japan 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 Kitakyusyu
Japan 81017 Kobe
Japan 81024 Kodaira
Japan 81010 Kokubunji
Japan 81032 Koushi
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 81009 Osakasayama
Japan 81011 Saitama
Japan 81042 Sakai
Japan 81025 Sapporo
Japan 81048 Sapporo
Japan 81053 Sapporo
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

Sponsors (2)

Lead Sponsor Collaborator
UCB Pharma SA UCB Japan Co. Ltd.

Countries where clinical trial is conducted

China,  Japan, 

References & Publications (1)

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;1291:56-68. doi: 10.1111/nyas.12213. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period Partial-onset seizure (POS) frequency per 28 days was calculated as:
POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.
A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period.
8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8) No
Secondary The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate) 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8) No
Secondary Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period. 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8) No
Secondary Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period) Partial-onset seizure (POS) frequency per 28 days was calculated as:
POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.
A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period.
8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8) No
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