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

Epilepsy Clinical Trial

Official title:

A Multi-center, Open-label, Uncontrolled, Long-term, Extension Study to Evaluate the Safety and Efficacy of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Partial-onset Seizures With or Without Secondary Generalization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832038
• Other study ID #: EP0009
• Status: Completed
• Phase: Phase 3
• Start date: March 26, 2013
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2021
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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]

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subject has completed the Treatment and Transition Period of EP0008 [NCT01710657]

Exclusion Criteria:

• Subjects who withdrew from EP0008 [NCT01710657]

Related Conditions & MeSH terms

• Epilepsy
• Partial-onset Seizures
• Seizures

Intervention

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.

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	86007	Guangzhou
China	86008	Guangzhou
China	86009	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	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	81013	Fukuoka
Japan	81054	Fukuoka
Japan	81057	Hachinohe
Japan	81027	Hamamatsu
Japan	81004	Himeji
Japan	81018	Hiroshima
Japan	81019	Iwanuma
Japan	81012	Kagoshima
Japan	81033	Kitakyushu
Japan	81017	Kobe
Japan	81024	Kodaira
Japan	81010	Kokubunji
Japan	81032	Koshi
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	81005	Okayama
Japan	81009	Osakasayama
Japan	81011	Saitama
Japan	81042	Sakai
Japan	81025	Sapporo
Japan	81053	Sapporo
Japan	81021	Shimotsuke
Japan	81022	Shimotsuke
Japan	81026	Shinjuku
Japan	81003	Shizuoka
Japan	81023	Suita
Japan	81051	Suita
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)

Inoue Y, Liao W, Wang X, Du X, Tennigkeit F, Sasamoto H, Osakabe T, Hoshii N, Yuen N, Hong Z. Safety and efficacy of adjunctive lacosamide in Chinese and Japanese adults with epilepsy and focal seizures: A long-term, open-label extension of a randomized, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From Visit 1 (Week 0) up to approximately Week 323
Primary	Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit	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.	From Visit 1 (Week 0) up to approximately Week 323
Secondary	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	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].	From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009
Secondary	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	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].	From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009

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