A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures
- Conditions
- EpilepsyPartial Onset Seizures
- Interventions
- Registration Number
- NCT01710657
- Lead Sponsor
- UCB Pharma SA
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 548
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching placebo for 16 weeks. Lacosamide 200 mg/day Lacosamide 50 mg Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks. Lacosamide 200 mg/day Lacosamide 100 mg Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks. Lacosamide 400 mg/day Lacosamide 100 mg Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks. Lacosamide 400 mg/day Lacosamide 50 mg Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.
- Primary Outcome Measures
Name Time Method Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period 8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8) 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.
- Secondary Outcome Measures
Name Time Method 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) Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8) 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.
Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period) 8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8) 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.
Trial Locations
- Locations (76)
86025
🇨🇳Shanghai, China
86012
🇨🇳Nanchang, China
86024
🇨🇳Wuhan, China
86029
🇨🇳Xiamen, China
81019
🇯🇵Iwanuma, Japan
81042
🇯🇵Sakai, Japan
81048
🇯🇵Sapporo, Japan
81035
🇯🇵Nagakute, Japan
81020
🇯🇵Sendai, Japan
81054
🇯🇵Fukuoka, Japan
81004
🇯🇵Himeji, Japan
81047
🇯🇵Kyoto, Japan
81025
🇯🇵Sapporo, Japan
81016
🇯🇵Takatsuki, Japan
81013
🇯🇵Fukuoka, Japan
81029
🇯🇵Nagoya, Japan
81007
🇯🇵Neyagawa, Japan
81002
🇯🇵Niigata, Japan
81022
🇯🇵Shimotsuke, Japan
81023
🇯🇵Suita, Japan
81006
🇯🇵Toyonaka, Japan
81050
🇯🇵Ube, Japan
81001
🇯🇵Yamagata, Japan
86019
🇨🇳Jinan, China
86004
🇨🇳Kunming, China
81010
🇯🇵Kokubunji, Japan
86006
🇨🇳Chongqing, China
86026
🇨🇳Beijing, China
86015
🇨🇳Changchun, China
86013
🇨🇳Guangzhou, China
86003
🇨🇳Qingdao, China
86023
🇨🇳Shanghai, China
86028
🇨🇳Nanjing, China
86007
🇨🇳Guangzhou, China
86001
🇨🇳Shanghai, China
81056
🇯🇵Asaka, Japan
86027
🇨🇳Beijing, China
86005
🇨🇳Chengdu, China
81057
🇯🇵Hachinohe, Japan
81008
🇯🇵Hakodate, Japan
86032
🇨🇳Chengdu, China
86016
🇨🇳Guangzhou, China
86011
🇨🇳Nanchang, China
86031
🇨🇳Dalian, China
86009
🇨🇳Guanghzou, China
86008
🇨🇳Guangzhou, China
86014
🇨🇳Hangzhou, China
81012
🇯🇵Kagoshima, Japan
81033
🇯🇵Kitakyusyu, Japan
81017
🇯🇵Kobe, Japan
81028
🇯🇵Nagoya, Japan
86021
🇨🇳Shenyang, China
86022
🇨🇳Suzhou, China
86020
🇨🇳Shijiazhuang, China
86002
🇨🇳Taiyuan, China
86018
🇨🇳Wuhan, China
81018
🇯🇵Hiroshima, Japan
86017
🇨🇳Xi'An, China
81027
🇯🇵Hamamatsu, Japan
81024
🇯🇵Kodaira, Japan
81014
🇯🇵Kurume, Japan
81032
🇯🇵Koushi, Japan
81040
🇯🇵Nara, Japan
81046
🇯🇵Ohmura, Japan
81011
🇯🇵Saitama, Japan
81031
🇯🇵Sendai, Japan
81053
🇯🇵Sapporo, Japan
81052
🇯🇵Suita, Japan
81003
🇯🇵Shizuoka, Japan
86010
🇨🇳Harbin, China
81030
🇯🇵Fujisawa, Japan
81005
🇯🇵Okayama, Japan
81009
🇯🇵Osakasayama, Japan
81021
🇯🇵Shimotsuke, Japan
81026
🇯🇵Shinjuku, Japan
81051
🇯🇵Suita, Japan