Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures

PHASE3CompletedINTERVENTIONAL
Enrollment

473

Participants

Timeline

Start Date

March 26, 2013

Primary Completion Date

July 31, 2019

Study Completion Date

July 31, 2019

Conditions
EpilepsyPartial-onset Seizures
Interventions
DRUG

Lacosamide

"Strength: Lacosamide (LCM) 50 mg, LCM 100 mg~Formulation: Tablet~Frequency: twice daily during the study period (until the date of approval)~At the completion of EP0008 \[NCT01710657\], all subjects who choose to enroll in EP0009 will be taking a dose of Lacosamide 200 mg/day. At the beginning of EP0009, the investigator may maintain the LCM dose or increase or decrease the dose. During the Treatment Period, the investigator will be allowed to increase or decrease the dose of LCM to optimize tolerability and seizure reduction. The LCM dose may be decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day."

Trial Locations (67)

Unknown

86026, Beijing

86027, Beijing

86015, Changchun

86005, Chengdu

86032, Chengdu

86006, Chongqing

86031, Dalian

86007, Guangzhou

86008, Guangzhou

86009, Guangzhou

86013, Guangzhou

86016, Guangzhou

86014, Hangzhou

86010, Harbin

86019, Jinan

86004, Kunming

86011, Nanchang

86012, Nanchang

86028, Nanjing

86003, Qingdao

86001, Shanghai

86023, Shanghai

86025, Shanghai

86020, Shijiazhuang

86022, Suzhou

86002, Taiyuan

86018, Wuhan

86024, Wuhan

86017, Xi'an

86029, Xiamen

81056, Asaka

81013, Fukuoka

81054, Fukuoka

81057, Hachinohe

81027, Hamamatsu

81004, Himeji

81018, Hiroshima

81019, Iwanuma

81012, Kagoshima

81033, Kitakyushu

81017, Kobe

81024, Kodaira

81010, Kokubunji

81032, Kōshi

81014, Kurume

81047, Kyoto

81035, Nagakute

81028, Nagoya

81029, Nagoya

81040, Nara

81007, Neyagawa

81002, Niigata

81005, Okayama

81011, Saitama

81042, Sakai

81025, Sapporo

81053, Sapporo

81009, Sayama

81021, Shimotsuke

81022, Shimotsuke

81026, Shinjuku

81003, Shizuoka

81023, Suita

81051, Suita

81006, Toyonaka

81050, Ube

81001, Yamagata

All Listed Sponsors
collaborator

UCB Japan Co. Ltd.

INDUSTRY

lead

UCB Pharma SA

INDUSTRY

NCT01832038 - Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures | Biotech Hunter | Biotech Hunter