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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01921205




Registration number
NCT01921205
Ethics application status
Date submitted
8/08/2013
Date registered
13/08/2013
Date last updated
18/07/2018

Titles & IDs
Public title
Study to Investigate Lacosamide as Add-on Therapy in Subjects =4 Years to <17 Years of Age 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 =4 Years to <17 Years of Age With Partial Onset Seizures
Secondary ID [1] 0 0
2012-004996-38
Secondary ID [2] 0 0
SP0969
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 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 -

Placebo comparator: Placebo -


Treatment: Drugs: Lacosamide
Subjects \<30 kg (LCM oral solution): 4 mg/kg - 6 mg/kg BID ( 8mg/kg/day - 12 mg/kg/day)

Subjects =30 kg to \<50 kg (LCM oral solution): 3 mg/kg - 4 mg/kg BID (6 mg/kg/day - 8 mg/kg/day)

Subjects =50 kg (LCM tablets): 150 mg - 200 mg BID (300 mg/day - 400 mg/day)

Other interventions: Placebo
Subjects \<30 kg (placebo oral solution): 4 mg/kg - 6 mg/kg BID (8 mg/kg/day - 12 mg/kg/day)

Subjects =30 kg to \<50 kg (placebo oral solution): 3 mg/kg - 4 mg/kg BID (6 mg/kg/day - 8 mg/kg/day)

Subjects =50 kg (placebo tablets): 150 mg - 200 mg BID (300 mg/day - 400 mg/day)
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
Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period
Timepoint [1] 0 0
Baseline to Week 16 (or last value on treatment)
Secondary outcome [1] 0 0
Proportion of Responders Where a Responder is Defined as a Participant With >= 50% Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period
Timepoint [1] 0 0
Baseline to Week 16 (or last value on treatment)
Secondary outcome [2] 0 0
Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the End of Maintenance Period
Timepoint [2] 0 0
Baseline to Week 16 (or last value on treatment)
Secondary outcome [3] 0 0
Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)
Timepoint [3] 0 0
Baseline to Week 16 (or last value on treatment)
Secondary outcome [4] 0 0
Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)
Timepoint [4] 0 0
Baseline to Week 16 (or last value on treatment)
Secondary outcome [5] 0 0
Proportion of Subjects Experiencing no Change in Partial Onset Seizure Frequency (Between <25 % Reduction and <25 % Increase) Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)
Timepoint [5] 0 0
Baseline to Week 16 (or last value on treatment)
Secondary outcome [6] 0 0
Proportion of Subjects Experiencing an Increase in Partial Onset Seizure Frequency Per 28 Days of >=25 % From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)
Timepoint [6] 0 0
Baseline to Week 16 (or last value on treatment)
Secondary outcome [7] 0 0
Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Simple Partial Seizures
Timepoint [7] 0 0
Baseline to Week 16 (or last value on treatment)
Secondary outcome [8] 0 0
Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Complex Partial Seizures
Timepoint [8] 0 0
Baseline to Week 16 (or last value on treatment)
Secondary outcome [9] 0 0
Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Secondary Generalized Seizures
Timepoint [9] 0 0
Baseline to Week 16 (or last value on treatment)
Secondary outcome [10] 0 0
Proportion of Seizure Free Days During the Maintenance Period for Subjects Who Completed the Maintenance Period
Timepoint [10] 0 0
Week 7 to Week 16
Secondary outcome [11] 0 0
Proportion of Subjects Who Achieved "Seizure Free" Status (Yes/no) for Subjects Who Completed the Maintenance Period
Timepoint [11] 0 0
Week 7 to Week 16

Eligibility
Key inclusion criteria
* An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the parent(s) or legal representative. The Informed Consent form or a specific Assent form, where required, will be signed and dated by minors
* Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator
* Subject is male or female from =4 years to <17 years of age
* Subject has a diagnosis of Epilepsy with partial-onset seizures. The results of =1 prior electroencephalogram (EEG) AND 1 prior magnetic resonance imaging/computerized tomography scan should be consistent with the above diagnosis
* Subject has been observed to have uncontrolled partial-onset seizures after an adequate course of treatment (in the opinion of the investigator) with =2 Anti-Epileptic Drugs (AEDs) (concurrently or sequentially)
* Subject must have been observed to have on average =2 partial onset seizures per 28 days with seizure free phase no longer than 21 days in the 8 week period prior to entry into the Baseline Period. During this study, subjects must have reported =2 partial onset seizures during the 8 week prospective Baseline Period to be eligible for randomization at Visit 2. (Note: In the case of simple partial onset seizures, only those seizures with motor signs will be counted towards meeting the inclusion criterion.)
* Subject is on a stable dosage regimen of 1 to =3 AEDs. The daily dosage regimen of concomitant AED therapy must be kept constant for a period of =4 weeks prior to the Baseline Period
* Vagal nerve stimulation (VNS) is allowed and will not be counted as a concomitant AED. The VNS device must be implanted for =6 months before Visit 1, and the device settings must be stable for =4 weeks before Visit 1 and be kept stable during the Baseline Period. Use of the VNS device magnet is allowed
Minimum age
4 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject has previously participated in this study or subject has been assigned to Lacosamide (LCM) in a previous LCM study
* Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within =2 months of Visit 1 or is currently participating in another study of an IMP or a medical device
* Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
* Subject =6 years of age has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has 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 known hypersensitivity to any component of the IMP or has ever received LCM
* Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception (according to International Conference on Harmonisation [ICH] guidance defined as those that result in a failure rate of less than 1% per year when used consistently and correctly), unless sexually abstinent, for the duration of the study. Female subject of childbearing potential taking enzyme inducing antiepileptic drugs (EI AEDs: carbamazepine, phenytoin, barbiturates, primidone, topiramate, oxcarbazepine) who is not surgically sterile or does not practice 1 highly effective method of contraception according to the WHO recommendation (ie, depot medroxyprogesterone acetate, norethisterone enantate, intrauterine devices, combined injectables, and progestogen implants) with administration of EI AEDs OR does not practice 2 combined methods of contraception (ie, combined hormonal contraception plus barrier method with spermicidal agent), unless sexually abstinent, for the duration of the study
* Subject has a medical condition that could be expected in the opinion of the investigator to interfere with drug absorption, distribution, metabolism, or excretion
* Subject has experienced febrile seizures exclusively. The occurrence of febrile seizures in addition to other unprovoked seizures is not exclusionary
* Subject is on a ketogenic or other specialized diet. If the subject was on a specialized diet in the past, they must be off the diet for =2 months prior to the Baseline Period
* Subject has an alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin level =2 times the upper limit of normal (ULN), or creatinine clearance less than 30 mL/min
* 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] greater than 450 ms)
* Subject has hemodynamically significant congenital heart disease
* Subject has an arrhythmic heart condition requiring medical therapy
* Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias
* Subject has nonepileptic events that could be confused with seizures
* Subject has a current diagnosis of Lennox-Gastaut syndrome, primary generalized epilepsy, mixed seizure disorder (partial and primarily generalized seizures), or purely nocturnal seizures
* Subject has a history of convulsive status epilepticus =2 months prior to the Baseline Period
* Subject has been treated with vigabatrin and experienced any vision loss. Subjects who have received vigabatrin in the past must have documentation of an assessment for vision loss prior to study entry or documentation of why visual field testing cannot be performed
* 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. Note: any subject who has been treated with felbamate for =12 months and has not experienced serious toxicity issues is eligible
* Subject has a medically documented history of alcohol or drug abuse
* Subject has a known cardiac sodium channelopathy, such as Brugada syndrome
* Subject has an acute or sub acutely 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)

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/01/2017
Sample size
Target
Accrual to date
Final
404
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
200 - Heidelberg West
Recruitment hospital [2] 0 0
203 - Herston
Recruitment hospital [3] 0 0
205 - South Brisbane
Recruitment postcode(s) [1] 0 0
- Heidelberg West
Recruitment postcode(s) [2] 0 0
- Herston
Recruitment postcode(s) [3] 0 0
- South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Argentina
State/province [11] 0 0
Buenos Aires
Country [12] 0 0
Argentina
State/province [12] 0 0
Cordoba
Country [13] 0 0
Belgium
State/province [13] 0 0
Brussels
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Bulgaria
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Sofia
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Colombia
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Floridablanca
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Colombia
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Medellin
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Croatia
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Osijek
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Croatia
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Rijeka
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Croatia
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Zagreb
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Czechia
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Hradec Kralove
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Czechia
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Ostrava-Poruba
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Czechia
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Praha 4
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Czechia
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Praha 5
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Estonia
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Tallinn
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Estonia
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Tartu
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Georgia
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Tbilisi
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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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Miskolc
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Hungary
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Pecs
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Israel
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Holon
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Israel
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Kfar Saba
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Italy
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Bologna
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Italy
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Florence
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Italy
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Genova
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Italy
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Mantova
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Italy
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Milano
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Italy
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Padova
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Italy
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Roma
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Italy
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Verona
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Latvia
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Riga
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Latvia
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Valmiera
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Lithuania
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Kaunas
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Mexico
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Culiacan
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Mexico
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Guadalajara
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Kielce
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Poznan
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Szczecin
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Tyniec Maly
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Warszawa
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Wroclaw
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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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Sibiu
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Romania
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Suceava
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Romania
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Timisoara
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Smolensk
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Russian Federation
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St. Petersburg
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Russian Federation
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Voronezh
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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 Beograd
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Serbia
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Novi Sad
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Slovakia
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Bardejov
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Slovakia
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Nitra
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Slovakia
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Nove Zamky
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Slovenia
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Ljubljana
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Taiwan
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Changhua
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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
State/province [82] 0 0
Bangkoknoi
Country [83] 0 0
Thailand
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Bangkok
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Thailand
State/province [84] 0 0
Muang
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Thailand
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Pathumwan
Country [86] 0 0
Thailand
State/province [86] 0 0
Ratchathewi
Country [87] 0 0
Ukraine
State/province [87] 0 0
Dnipropetrovsk
Country [88] 0 0
Ukraine
State/province [88] 0 0
Kiev
Country [89] 0 0
Ukraine
State/province [89] 0 0
Uzhgorod
Country [90] 0 0
Ukraine
State/province [90] 0 0
Vinnitsa
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Birmingham
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study to evaluate the efficacy of Lacosamide (LCM) administered in addition to 1 to =3 other Anti-Epileptic Drugs in subjects with epilepsy =4 years to \<17 years of age who currently have uncontrolled partial onset seizures.
Trial website
https://clinicaltrials.gov/study/NCT01921205
Trial related presentations / publications
Johnson ME, McClung C, Bozorg AM. Analyses of seizure responses supportive of a novel trial design to assess efficacy of antiepileptic drugs in infants and young children with epilepsy: Post hoc analyses of pediatric levetiracetam and lacosamide trials. Epilepsia Open. 2021 Jun;6(2):359-368. doi: 10.1002/epi4.12482. Epub 2021 May 3.
Babar RK, Bresnahan R, Gillespie CS, Michael BD. Lacosamide add-on therapy for focal epilepsy. Cochrane Database Syst Rev. 2021 May 17;5(5):CD008841. doi: 10.1002/14651858.CD008841.pub3.
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
+1 877 822 9493
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01921205