A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Uncontrolled Partial-Onset Seizures With or Without Secondary Generalization
3 other identifiers
interventional
548
2 countries
76
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2012
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 17, 2012
CompletedFirst Posted
Study publicly available on registry
October 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
February 9, 2015
CompletedAugust 25, 2017
July 1, 2017
1.8 years
October 17, 2012
January 22, 2015
July 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period
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.
8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)
Secondary Outcomes (3)
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)
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)
Study Arms (3)
Placebo
PLACEBO COMPARATORMatching placebo for 16 weeks.
Lacosamide 200 mg/day
EXPERIMENTALLacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks.
Lacosamide 400 mg/day
EXPERIMENTALLacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.
Interventions
* Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 50 mg * Route of Administration: Oral use
* Active Substance: Lacosamide * Pharmaceutical Form: Film-coated tablet * Concentration: 100 mg * Route of Administration: Oral use
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharma SAlead
- UCB Japan Co. Ltd.collaborator
Study Sites (76)
86026
Beijing, China
86027
Beijing, China
86015
Changchun, China
86005
Chengdu, China
86032
Chengdu, China
86006
Chongqing, China
86031
Dalian, China
86009
Guanghzou, China
86007
Guangzhou, China
86008
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
86021
Shenyang, China
86020
Shijiazhuang, China
86022
Suzhou, China
86002
Taiyuan, China
86018
Wuhan, China
86024
Wuhan, China
86017
Xi'an, China
86029
Xiamen, China
81056
Asaka, Japan
81030
Fujisawa, Japan
81013
Fukuoka, Japan
81054
Fukuoka, Japan
81057
Hachinohe, Japan
81008
Hakodate, 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
Kōshi, 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
81046
Ohmura, Japan
81005
Okayama, Japan
81011
Saitama, Japan
81042
Sakai, Japan
81025
Sapporo, Japan
81048
Sapporo, Japan
81053
Sapporo, Japan
81009
Sayama, Japan
81020
Sendai, Japan
81031
Sendai, Japan
81021
Shimotsuke, Japan
81022
Shimotsuke, Japan
81026
Shinjuku, Japan
81003
Shizuoka, Japan
81023
Suita, Japan
81051
Suita, Japan
81052
Suita, Japan
81016
Takatsuki, Japan
81006
Toyonaka, Japan
81050
Ube, Japan
81001
Yamagata, Japan
Related Publications (1)
Doty P, Hebert D, Mathy FX, Byrnes W, Zackheim J, Simontacchi K. Development of lacosamide for the treatment of partial-onset seizures. Ann N Y Acad Sci. 2013 Jul;1291(1):56-68. doi: 10.1111/nyas.12213.
PMID: 23859801RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2012
First Posted
October 19, 2012
Study Start
September 1, 2012
Primary Completion
July 1, 2014
Study Completion
August 1, 2014
Last Updated
August 25, 2017
Results First Posted
February 9, 2015
Record last verified: 2017-07