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

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

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]

Study Overview

• Status: Completed
• Conditions: Epilepsy; Partial-onset Seizures
• Intervention / Treatment: Drug: Lacosamide

• Study Type: Interventional
• Enrollment (Actual): 473
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • 86026
  • Beijing, China
    • 86027
  • Changchun, China
    • 86015
  • Chengdu, China
    • 86005
  • Chengdu, China
    • 86032
  • Chongqing, China
    • 86006
  • Dalian, China
    • 86031
  • Guangzhou, China
    • 86007
  • Guangzhou, China
    • 86008
  • Guangzhou, China
    • 86013
  • Guangzhou, China
    • 86016
  • Guangzhou, China
    • 86009
  • Hangzhou, China
    • 86014
  • Harbin, China
    • 86010
  • Jinan, China
    • 86019
  • Kunming, China
    • 86004
  • Nanchang, China
    • 86011
  • Nanchang, China
    • 86012
  • Nanjing, China
    • 86028
  • Qingdao, China
    • 86003
  • Shanghai, China
    • 86001
  • Shanghai, China
    • 86023
  • Shanghai, China
    • 86025
  • Shijiazhuang, China
    • 86020
  • Suzhou, China
    • 86022
  • Taiyuan, China
    • 86002
  • Wuhan, China
    • 86018
  • Wuhan, China
    • 86024
  • Xi'an, China
    • 86017
  • Xiamen, China
    • 86029
• Japan
  • Asaka, Japan
    • 81056
  • Fukuoka, Japan
    • 81013
  • Fukuoka, Japan
    • 81054
  • Hachinohe, Japan
    • 81057
  • Hamamatsu, Japan
    • 81027
  • Himeji, Japan
    • 81004
  • Hiroshima, Japan
    • 81018
  • Iwanuma, Japan
    • 81019
  • Kagoshima, Japan
    • 81012
  • Kitakyushu, Japan
    • 81033
  • Kobe, Japan
    • 81017
  • Kodaira, Japan
    • 81024
  • Kokubunji, Japan
    • 81010
  • Koshi, Japan
    • 81032
  • Kurume, Japan
    • 81014
  • Kyoto, Japan
    • 81047
  • Nagakute, Japan
    • 81035
  • Nagoya, Japan
    • 81028
  • Nagoya, Japan
    • 81029
  • Nara, Japan
    • 81040
  • Neyagawa, Japan
    • 81007
  • Niigata, Japan
    • 81002
  • Okayama, Japan
    • 81005
  • Osakasayama, Japan
    • 81009
  • Saitama, Japan
    • 81011
  • Sakai, Japan
    • 81042
  • Sapporo, Japan
    • 81025
  • Sapporo, Japan
    • 81053
  • Shimotsuke, Japan
    • 81021
  • Shimotsuke, Japan
    • 81022
  • Shinjuku, Japan
    • 81026
  • Shizuoka, Japan
    • 81003
  • Suita, Japan
    • 81023
  • Suita, Japan
    • 81051
  • Toyonaka, Japan
    • 81006
  • Ube, Japan
    • 81050
  • Yamagata, Japan
    • 81001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Subjects who withdrew from EP0008 [NCT01710657]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lacosamide; Lacosamide treatment of 100 - 400 mg/day for long-term

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.; Other Names: Vimpat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: UCB Pharma SA
• Collaborators: UCB Japan Co. Ltd.

Publications and helpful links

General Publications

• 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, controlled trial. Epilepsy Res. 2021 Oct;176:106705. doi: 10.1016/j.eplepsyres.2021.106705. Epub 2021 Jun 29.

Helpful Links

• FDA Safety Alerts and Recalls
• Product Information

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2013
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: March 28, 2013
• First Submitted That Met QC Criteria: April 10, 2013
• First Posted (Estimate): April 15, 2013

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Epilepsy; Lacosamide; Partial-onset Seizures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lacosamide
• Other Study ID Numbers: EP0009