Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
- Registration Number
- NCT01832038
- Lead Sponsor
- UCB Pharma SA
- Brief Summary
The purpose of this trial is to evaluate the safety and tolerability of long-term administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with Epilepsy who have completed the Treatment and Transition Period of EP0008 \[NCT01710657\]
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 473
- Subject has completed the Treatment and Transition Period of EP0008 [NCT01710657]
- Subjects who withdrew from EP0008 [NCT01710657]
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lacosamide Lacosamide Lacosamide treatment of 100 - 400 mg/day for long-term
- Primary Outcome Measures
Name Time Method Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit From Visit 1 (Week 0) up to approximately Week 323 An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit From Visit 1 (Week 0) up to approximately Week 323 An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment and led to the withdrawal of the participants from the study. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
- Secondary Outcome Measures
Name Time Method Percent Change in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009 From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009 The percent change from Baseline to the Treatment Period was calculated as {\[(Seizure frequency per 28 days during the Treatment Period) minus (Seizure frequency per 28 days during Baseline Period)\] divided by (Seizure frequency per 28 days during Baseline Period)} multiplied by 100. Baseline was defined as the Baseline Period of study EP0008 \[NCT01710657\].
Percentage of Participants With 50 % Response Rate in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009 From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009 A responder is a subject experiencing a greater than or equal to (≥) 50 % reduction in partial-onset seizure frequency per 28 days from baseline. Baseline was defined as the Baseline Period of study EP0008 \[NCT01710657\].
Trial Locations
- Locations (67)
86019
🇨🇳Jinan, China
86004
🇨🇳Kunming, China
86012
🇨🇳Nanchang, China
86025
🇨🇳Shanghai, China
86008
🇨🇳Guangzhou, China
86027
🇨🇳Beijing, China
86017
🇨🇳Xi'an, China
81028
🇯🇵Nagoya, Japan
81007
🇯🇵Neyagawa, Japan
81053
🇯🇵Sapporo, Japan
81022
🇯🇵Shimotsuke, Japan
81026
🇯🇵Shinjuku, Japan
81023
🇯🇵Suita, Japan
81001
🇯🇵Yamagata, Japan
81051
🇯🇵Suita, Japan
81024
🇯🇵Kodaira, Japan
81017
🇯🇵Kobe, Japan
86001
🇨🇳Shanghai, China
86018
🇨🇳Wuhan, China
86015
🇨🇳Changchun, China
86016
🇨🇳Guangzhou, China
86014
🇨🇳Hangzhou, China
86011
🇨🇳Nanchang, China
86023
🇨🇳Shanghai, China
86022
🇨🇳Suzhou, China
86002
🇨🇳Taiyuan, China
81054
🇯🇵Fukuoka, Japan
86029
🇨🇳Xiamen, China
86005
🇨🇳Chengdu, China
86006
🇨🇳Chongqing, China
86010
🇨🇳Harbin, China
86024
🇨🇳Wuhan, China
81003
🇯🇵Shizuoka, Japan
81006
🇯🇵Toyonaka, Japan
81056
🇯🇵Asaka, Japan
81018
🇯🇵Hiroshima, Japan
81029
🇯🇵Nagoya, Japan
81011
🇯🇵Saitama, Japan
86026
🇨🇳Beijing, China
86032
🇨🇳Chengdu, China
86007
🇨🇳Guangzhou, China
86013
🇨🇳Guangzhou, China
81025
🇯🇵Sapporo, Japan
81032
🇯🇵Koshi, Japan
81010
🇯🇵Kokubunji, Japan
81005
🇯🇵Okayama, Japan
81042
🇯🇵Sakai, Japan
81057
🇯🇵Hachinohe, Japan
81047
🇯🇵Kyoto, Japan
86009
🇨🇳Guangzhou, China
81035
🇯🇵Nagakute, Japan
81013
🇯🇵Fukuoka, Japan
81004
🇯🇵Himeji, Japan
81019
🇯🇵Iwanuma, Japan
81021
🇯🇵Shimotsuke, Japan
81014
🇯🇵Kurume, Japan
81027
🇯🇵Hamamatsu, Japan
81002
🇯🇵Niigata, Japan
81033
🇯🇵Kitakyushu, Japan
86031
🇨🇳Dalian, China
86003
🇨🇳Qingdao, China
86020
🇨🇳Shijiazhuang, China
81012
🇯🇵Kagoshima, Japan
81040
🇯🇵Nara, Japan
81009
🇯🇵Osakasayama, Japan
81050
🇯🇵Ube, Japan
86028
🇨🇳Nanjing, China