A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures

Epilepsy Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Uncontrolled Partial-Onset Seizures With or Without Secondary Generalization

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

• Epilepsy
• Partial Onset Seizures
• Seizures

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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