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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02477839




Registration number
NCT02477839
Ethics application status
Date submitted
13/05/2015
Date registered
23/06/2015
Date last updated
30/03/2020

Titles & IDs
Public title
Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects =1 Month to <4 Years With Partial-onset Seizures
Scientific title
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects With Epilepsy >=1 Month to <4 Years of Age With Partial-Onset Seizures
Secondary ID [1] 0 0
2013-000717-20
Secondary ID [2] 0 0
SP0967
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy With Partial-onset Seizures 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Lacosamide
Other interventions - Placebo

Experimental: Lacosamide - Lacosamide syrup 8 mg/kg/day to 12 mg/kg/day

Placebo Comparator: Placebo - Matching placebo syrup


Treatment: Drugs: Lacosamide
Active Substance: Lacosamide Pharmaceutical Form: Syrup Concentration: 10 mg/mL Route of Administration: oral

Other interventions: Placebo
Active Substance: Placebo Pharmaceutical Form: Syrup Concentration: N/A Route of Administration: oral

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Applicable for the US only if dropout rate is <=10%: The change in average daily frequency (ADF) of electrographic partial-onset seizures - The change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-electroencephalogram (EEG) compared to the End-of-Baseline Period video-EEG
Timepoint [1] 0 0
End-of-Baseline Perio to End-of-Maintenance Period
Primary outcome [2] 0 0
Applicable for the EU and for the US if dropout rate is >10%: Proportion of responders: >= 50% reduction in partial onset seizure frequency from Baseline to the Maintenance Period - The proportion of responders where a responder is a subject experiencing a 50% or greater reduction in their average daily frequency of electrographic partial-onset seizures recorded on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG
Timepoint [2] 0 0
End-of-Baseline Period to End-of-Maintenance Period
Primary outcome [3] 0 0
Subject withdrawals due to Adverse Events (AEs) during the study
Timepoint [3] 0 0
From the Titration Period (day 1) to the End of Study Visit (up to 93 days)
Primary outcome [4] 0 0
Incidence of Adverse events reported spontaneously by the subject's parent(s) and/or legal representative(s)/caregiver(s) (in accordance with local regulation) or observed by the investigator
Timepoint [4] 0 0
Baseline Period to End-of-Maintenance Period
Secondary outcome [1] 0 0
Absolute change in average daily frequency (ADF) of electrographic partial-onset seizures - The absolute change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG
Timepoint [1] 0 0
End-of-Baseline Period to End-of-Maintenance Period
Secondary outcome [2] 0 0
Percent change in average daily frequency (ADF) of electrographic partial-onset seizures - The percent change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG
Timepoint [2] 0 0
End-of-Baseline Period to End-of-Maintenance Period
Secondary outcome [3] 0 0
Proportion of subjects who achieved "seizure-free" status from all seizure types - Proportion of subjects who achieved "seizure-free" status (yes/no) from all seizure types for subjects who completed at least 48 hours of interpretable video-EEG recording during the End-of-Maintenance Period video-EEG
Timepoint [3] 0 0
During the End-of-Maintenance Period
Secondary outcome [4] 0 0
Proportion of subjects who achieved "seizure-free" status from partial-onset seizure types only - Proportion of subjects who achieved "seizure-free" status (yes/no) from partial-onset seizure types only for subjects who completed at least 48 hours of interpretable video-EEG recording during the End-of-Maintenance Period video-EEG
Timepoint [4] 0 0
During the End-of-Maintenance Period
Secondary outcome [5] 0 0
Proportion of subjects experiencing a >=25% to <50% reduction in average daily frequency (ADF) of electrographic partial-onset seizures - Proportion of subjects experiencing a >=25% to <50% reduction in ADF of electrographic partial-onset seizures from the end-of-Baseline Period video-EEG to the End-of-Maintenance Period video-EEG
Timepoint [5] 0 0
End-of-Baseline Period to End-of-Maintenance Period
Secondary outcome [6] 0 0
Proportion of subjects experiencing a 50% to 75% reduction in average daily frequency (ADF) of electrographic partial-onset seizures - Proportion of subjects experiencing 50% to 75% reduction in ADF of electrographic partial-onset seizures from the end-of-Baseline Period video-EEG to the End-of-Maintenance Period video-EEG
Timepoint [6] 0 0
End-of-Baseline Period to End-of-Maintenance Period
Secondary outcome [7] 0 0
Proportion of subjects experiencing a >75% reduction in average daily frequency (ADF) of electrographic partial-onset seizures - Proportion of subjects experiencing a >75% reduction in ADF of electrographic partial-onset seizures from the end-of-Baseline Period video-EEG to the End-of-Maintenance Period video-EEG
Timepoint [7] 0 0
End-of-Baseline Period to End-of-Maintenance Period
Secondary outcome [8] 0 0
Proportion of subjects experiencing no change in average daily frequency (ADF) of electrographic partial-onset seizures (between <25% reduction and <25% increase) - Proportion of subjects experiencing no change in ADF of electrographic partial-onset seizures (between <25% reduction and <25% increase) from the End-of-Baseline Period video-EEG to the End-of-Maintenance Period video-EEG
Timepoint [8] 0 0
End-of-Baseline Period to End-of-Maintenance Period
Secondary outcome [9] 0 0
Proportion of subjects experiencing an increase in average daily frequency (ADF) of electrographic partial-onset seizures of >=25% - Proportion of subjects experiencing an increase in ADF of electrographic partial-onset seizures of >=25% from the End-of-Baseline Period video-EEG to the End-of-Maintenance Period video-EEG
Timepoint [9] 0 0
End-of-Baseline Period to End-of-Maintenance Period

Eligibility
Key inclusion criteria
- Subject is male or female from >=1 month (ie, 4 weeks after full term [37 weeks
gestational age]) to <4 years of age

- Subject has a diagnosis of epilepsy with partial-onset seizures. The results of >=1
prior EEG and >=1 magnetic resonance imaging/computerized tomography scan should be
consistent with this diagnosis

- Subject weighs >=4 kg to <30 kg at Visit 1

- Subject has experienced >=2 partial-onset seizures with or without secondary
generalization during each consecutive 7-day period during the 2 weeks prior to Visit
1

- Subject has >=2 partial-onset seizures with or without secondary generalization during
the End-of-Baseline video-EEG. Electrographic seizures are defined as recognizable
ictal patterns on an EEG involving >=2 contiguous electrodes. The seizures are
initiated as a unilateral or strongly asymmetric abnormal epileptiform discharge
lasting a total of >10 seconds

- Subject is on a stable (concurrently or sequentially) dosage regimen of 1 to 3 AEDs.
The dosage regimen of concomitant AED therapy must be kept constant for a period of
>=2 weeks prior to Visit 1. A stable daily dosage regimen of a concomitant
benzodiazepine (BZD) will be considered as a concomitant AED

- Vagus nerve stimulation (VNS) is allowed and will not be counted as a concomitant AED.
The VNS device must have been implanted for >=6 months prior to Visit 1; device
settings must be kept stable for >=2 weeks prior to Visit 1 and kept stable during the
Baseline, Treatment, and Transition Periods. Use of the VNS device magnet is allowed

- Subject is an acceptable candidate for venipuncture
Minimum age
1 Month
Maximum age
47 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject has experienced febrile seizures exclusively. The occurrence of febrile
seizures in addition to partial-onset seizures is not exclusionary

- Subject is on a ketogenic diet that has either changed within the 4 weeks prior to
Visit 1 or is expected to change during the study

- Subject has creatinine clearance <30 mL/minute

- Subject has a clinically relevant ECG abnormality, in the opinion of the investigator
(eg, second or third degree heart block at rest or a corrected QT interval [QTc] >=450
ms)

- Subject has a hemodynamically significant congenital heart disease

- Subject has an arrhythmic heart condition requiring medical therapy

- Subject has a known history of severe anaphylactic reaction secondary to medication
intake or serious blood dyscrasias

- Subject has nonepileptic events that could be confused with seizures. Subjects may be
included if epileptic events can be clearly distinguished and the frequency meets the
study inclusion criteria

- Subject has a current diagnosis of Lennox-Gastaut syndrome, epilepsia partialis
continua, primary generalized epilepsy, Dravet Syndorme, or seizures that are not of
partial-onset origin

- Subject has a history of generalized convulsive status epilepticus <=2 months prior to
Screening (Visit 1)

- Subject has been treated with felbamate and has experienced any serious toxicity
issues (defined as liver failure, aplastic anemia) with this treatment. Subjects
treated with felbamate for <12 months are excluded. Subjects treated with felbamate
for >=12 months prior to Visit 1 and who have not experienced serious toxicity issues
are eligible

- Subject has an acute or subacutely progressive central nervous system disease. Subject
has epilepsy secondary to a progressing cerebral disease or any other progressively
neurodegenerative disease (malignant brain tumor or Rasmussen Syndrome)

- Subject has a known cardiac sodium channelopathy, such as Brugada syndrome

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sp0967 200 - Heidelberg West
Recruitment postcode(s) [1] 0 0
- Heidelberg West
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
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United States of America
State/province [3] 0 0
Nevada
Country [4] 0 0
United States of America
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New Hampshire
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United States of America
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Texas
Country [6] 0 0
Argentina
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Córdoba
Country [7] 0 0
Belgium
State/province [7] 0 0
Brussels
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Brazil
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Passo Fundo
Country [9] 0 0
Brazil
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Porto Alegre
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Brazil
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São Paulo
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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China
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Beijing
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China
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Changchun
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China
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Chongqing
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China
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Hangzhou
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China
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Nanchang
Country [18] 0 0
China
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Shanghai
Country [19] 0 0
China
State/province [19] 0 0
Shenzhen
Country [20] 0 0
Croatia
State/province [20] 0 0
Osijek
Country [21] 0 0
Croatia
State/province [21] 0 0
Rijeka
Country [22] 0 0
Croatia
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Zagreb
Country [23] 0 0
Czechia
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Ostrava-Poruba
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Finland
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Helsinki
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France
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Amiens
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France
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Lille
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Marseille
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France
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Paris
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France
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Rennes
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France
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Rouen
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France
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Strasbourg
Country [32] 0 0
France
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Toulouse
Country [33] 0 0
Georgia
State/province [33] 0 0
Tbilisi
Country [34] 0 0
Germany
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Erlangen
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Germany
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Freiburg
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Greece
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Athens
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Greece
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Thessaloníki
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Hungary
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Balassagyarmat
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Pécs
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Israel
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Haifa
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Israel
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Petah tikva
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Italy
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Calambrone
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Italy
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Genova
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Italy
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Messina
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Italy
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Miano
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Italy
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Milano
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Napoli
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Roma
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Verona
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Seoul
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Suwon
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Lithuania
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Chihuahua
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Culiacán
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Monterrey
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Oaxaca de Juarez
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Moldova, Republic of
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Cebu
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Manila
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Quezon City
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Poland
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Kraków
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Lisboa
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Portugal
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Lisbon
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Romania
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Brasov
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Romania
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Bucuresti
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Romania
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Cluj-Napoca
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Romania
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Iasi
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Romania
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Sibiu
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Romania
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Timisoara
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Russian Federation
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Kemerovo
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Nizhny Novgorod
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Novosibirsk
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Omsk
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Perm
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Saint Petersburg
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Russian Federation
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Smolensk
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Russian Federation
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Tomsk
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Russian Federation
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Ulyanovsk
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Russian Federation
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Voronezh
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Russian Federation
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Yekaterinburg
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Novi Sad
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Slovakia
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Bratislava
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Spain
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Madrid
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Taiwan
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Taichung
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Pathum Wan
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Turkey
State/province [97] 0 0
Eskisehir
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Turkey
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Istanbul
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Turkey
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Izmir
Country [100] 0 0
Ukraine
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Dnipropetrovs'k
Country [101] 0 0
Ukraine
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Dnipro
Country [102] 0 0
Ukraine
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Ivano-Frankivs'k
Country [103] 0 0
Ukraine
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Kiev
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Ukraine
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Uzhgorod
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Ukraine
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Vinnytsia
Country [106] 0 0
Ukraine
State/province [106] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB BIOSCIENCES, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this trial is to assess the efficacy, safety and tolerabilty of lacosamide
administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for
children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled
partial-onset seizures.
Trial website
https://clinicaltrials.gov/show/NCT02477839
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
+1 877 822 9493 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications