Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Query!
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
Query!
Secondary ID [1]
0
0
2012-004996-38
Query!
Secondary ID [2]
0
0
SP0969
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Epilepsy
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Epilepsy
Query!
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
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)
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period
Query!
Assessment method [1]
0
0
The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
Query!
Timepoint [1]
0
0
Baseline to Week 16 (or last value on treatment)
Query!
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
Query!
Assessment method [1]
0
0
Proportion of responders is presented as percentage of participants. A responder is a subject experiencing a 50 % or greater reduction in partial onset seizure frequency per 28 days from Baseline to the Maintenance Period.
Query!
Timepoint [1]
0
0
Baseline to Week 16 (or last value on treatment)
Query!
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
Query!
Assessment method [2]
0
0
Proportion of subjects is presented as percentage of participants. A >=25%-<50% response in the Maintenance Period is defined as >=25% to <50% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. A >=50%-<=75% response in the Maintenance Period is defined as >=50% to <=75% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. A 75% response in the Maintenance Period is defined as >75% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period.
Query!
Timepoint [2]
0
0
Baseline to Week 16 (or last value on treatment)
Query!
Secondary outcome [3]
0
0
Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)
Query!
Assessment method [3]
0
0
The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
Query!
Timepoint [3]
0
0
Baseline to Week 16 (or last value on treatment)
Query!
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)
Query!
Assessment method [4]
0
0
Proportion of subjects is presented as percentage of participants. A >=25%-<50% response in the Treatment Period is defined as >=25% to <50% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. A >=50%-<=75% response in the Treatment Period is defined as >=50% to <=75% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. A 75% response in the Treatment Period is defined as >75% reduction in POS frequency per 28 days from Baseline to end of Treatment Period.
Query!
Timepoint [4]
0
0
Baseline to Week 16 (or last value on treatment)
Query!
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)
Query!
Assessment method [5]
0
0
Proportion of subjects is presented as percentage of participants. No change is defined as between <25% reduction and <25% increase in POS frequency per 28 days from Baseline to the entire Treatment Period, otherwise not between <25% reduction and <25% increase is defined as a change.
Query!
Timepoint [5]
0
0
Baseline to Week 16 (or last value on treatment)
Query!
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)
Query!
Assessment method [6]
0
0
Proportion of subjects is presented as percentage of participants. An increase is defined as a >=25% increase in POS frequency per 28 days from Baseline to the entire Treatment Period, otherwise <25% increase is defined as no increase.
Query!
Timepoint [6]
0
0
Baseline to Week 16 (or last value on treatment)
Query!
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
Query!
Assessment method [7]
0
0
The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
Query!
Timepoint [7]
0
0
Baseline to Week 16 (or last value on treatment)
Query!
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
Query!
Assessment method [8]
0
0
The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
Query!
Timepoint [8]
0
0
Baseline to Week 16 (or last value on treatment)
Query!
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
Query!
Assessment method [9]
0
0
The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
Query!
Timepoint [9]
0
0
Baseline to Week 16 (or last value on treatment)
Query!
Secondary outcome [10]
0
0
Proportion of Seizure Free Days During the Maintenance Period for Subjects Who Completed the Maintenance Period
Query!
Assessment method [10]
0
0
The proportion of seizure free days is calculated as (days with number of seizures = 0) divided by (days with recorded data in the subject diary), where 'days with recorded data in the subject diary' excludes any days where 'Not Done' is recorded.
Query!
Timepoint [10]
0
0
Week 7 to Week 16
Query!
Secondary outcome [11]
0
0
Proportion of Subjects Who Achieved "Seizure Free" Status (Yes/no) for Subjects Who Completed the Maintenance Period
Query!
Assessment method [11]
0
0
The proportion of seizure free days is calculated as (days with number of seizures = 0) divided by (days with recorded data in the subject diary), where 'days with recorded data in the subject diary' excludes any days where 'Not Done' is recorded.
Query!
Timepoint [11]
0
0
Week 7 to Week 16
Query!
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
Query!
Minimum age
4
Years
Query!
Query!
Maximum age
16
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
29/08/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
24/01/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
404
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
200 - Heidelberg West
Query!
Recruitment hospital [2]
0
0
203 - Herston
Query!
Recruitment hospital [3]
0
0
205 - South Brisbane
Query!
Recruitment postcode(s) [1]
0
0
- Heidelberg West
Query!
Recruitment postcode(s) [2]
0
0
- Herston
Query!
Recruitment postcode(s) [3]
0
0
- South Brisbane
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Colorado
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Kentucky
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Louisiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Nevada
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
North Carolina
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Oregon
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Texas
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Washington
Query!
Country [11]
0
0
Argentina
Query!
State/province [11]
0
0
Buenos Aires
Query!
Country [12]
0
0
Argentina
Query!
State/province [12]
0
0
Cordoba
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Brussels
Query!
Country [14]
0
0
Bulgaria
Query!
State/province [14]
0
0
Sofia
Query!
Country [15]
0
0
Colombia
Query!
State/province [15]
0
0
Floridablanca
Query!
Country [16]
0
0
Colombia
Query!
State/province [16]
0
0
Medellin
Query!
Country [17]
0
0
Croatia
Query!
State/province [17]
0
0
Osijek
Query!
Country [18]
0
0
Croatia
Query!
State/province [18]
0
0
Rijeka
Query!
Country [19]
0
0
Croatia
Query!
State/province [19]
0
0
Zagreb
Query!
Country [20]
0
0
Czechia
Query!
State/province [20]
0
0
Hradec Kralove
Query!
Country [21]
0
0
Czechia
Query!
State/province [21]
0
0
Ostrava-Poruba
Query!
Country [22]
0
0
Czechia
Query!
State/province [22]
0
0
Praha 4
Query!
Country [23]
0
0
Czechia
Query!
State/province [23]
0
0
Praha 5
Query!
Country [24]
0
0
Estonia
Query!
State/province [24]
0
0
Tallinn
Query!
Country [25]
0
0
Estonia
Query!
State/province [25]
0
0
Tartu
Query!
Country [26]
0
0
Georgia
Query!
State/province [26]
0
0
Tbilisi
Query!
Country [27]
0
0
Hungary
Query!
State/province [27]
0
0
Budapest
Query!
Country [28]
0
0
Hungary
Query!
State/province [28]
0
0
Debrecen
Query!
Country [29]
0
0
Hungary
Query!
State/province [29]
0
0
Miskolc
Query!
Country [30]
0
0
Hungary
Query!
State/province [30]
0
0
Pecs
Query!
Country [31]
0
0
Israel
Query!
State/province [31]
0
0
Holon
Query!
Country [32]
0
0
Israel
Query!
State/province [32]
0
0
Kfar Saba
Query!
Country [33]
0
0
Israel
Query!
State/province [33]
0
0
Petach Tikva
Query!
Country [34]
0
0
Israel
Query!
State/province [34]
0
0
Tel Aviv
Query!
Country [35]
0
0
Italy
Query!
State/province [35]
0
0
Bologna
Query!
Country [36]
0
0
Italy
Query!
State/province [36]
0
0
Florence
Query!
Country [37]
0
0
Italy
Query!
State/province [37]
0
0
Genova
Query!
Country [38]
0
0
Italy
Query!
State/province [38]
0
0
Mantova
Query!
Country [39]
0
0
Italy
Query!
State/province [39]
0
0
Milano
Query!
Country [40]
0
0
Italy
Query!
State/province [40]
0
0
Padova
Query!
Country [41]
0
0
Italy
Query!
State/province [41]
0
0
Roma
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Verona
Query!
Country [43]
0
0
Korea, Republic of
Query!
State/province [43]
0
0
Daegu
Query!
Country [44]
0
0
Korea, Republic of
Query!
State/province [44]
0
0
Seoul
Query!
Country [45]
0
0
Latvia
Query!
State/province [45]
0
0
Riga
Query!
Country [46]
0
0
Latvia
Query!
State/province [46]
0
0
Valmiera
Query!
Country [47]
0
0
Lithuania
Query!
State/province [47]
0
0
Kaunas
Query!
Country [48]
0
0
Mexico
Query!
State/province [48]
0
0
Culiacan
Query!
Country [49]
0
0
Mexico
Query!
State/province [49]
0
0
Guadalajara
Query!
Country [50]
0
0
Mexico
Query!
State/province [50]
0
0
Monterrey
Query!
Country [51]
0
0
Montenegro
Query!
State/province [51]
0
0
Podgorica
Query!
Country [52]
0
0
Poland
Query!
State/province [52]
0
0
Gdansk
Query!
Country [53]
0
0
Poland
Query!
State/province [53]
0
0
Katowice
Query!
Country [54]
0
0
Poland
Query!
State/province [54]
0
0
Kielce
Query!
Country [55]
0
0
Poland
Query!
State/province [55]
0
0
Krakow
Query!
Country [56]
0
0
Poland
Query!
State/province [56]
0
0
Poznan
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Szczecin
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Tyniec Maly
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Warszawa
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Wroclaw
Query!
Country [61]
0
0
Romania
Query!
State/province [61]
0
0
Bucuresti
Query!
Country [62]
0
0
Romania
Query!
State/province [62]
0
0
Cluj-Napoca
Query!
Country [63]
0
0
Romania
Query!
State/province [63]
0
0
Sibiu
Query!
Country [64]
0
0
Romania
Query!
State/province [64]
0
0
Suceava
Query!
Country [65]
0
0
Romania
Query!
State/province [65]
0
0
Timisoara
Query!
Country [66]
0
0
Russian Federation
Query!
State/province [66]
0
0
Kazan
Query!
Country [67]
0
0
Russian Federation
Query!
State/province [67]
0
0
Moscow
Query!
Country [68]
0
0
Russian Federation
Query!
State/province [68]
0
0
Smolensk
Query!
Country [69]
0
0
Russian Federation
Query!
State/province [69]
0
0
St. Petersburg
Query!
Country [70]
0
0
Russian Federation
Query!
State/province [70]
0
0
Voronezh
Query!
Country [71]
0
0
Serbia
Query!
State/province [71]
0
0
Belgrade
Query!
Country [72]
0
0
Serbia
Query!
State/province [72]
0
0
Kragujevac
Query!
Country [73]
0
0
Serbia
Query!
State/province [73]
0
0
Novi Beograd
Query!
Country [74]
0
0
Serbia
Query!
State/province [74]
0
0
Novi Sad
Query!
Country [75]
0
0
Slovakia
Query!
State/province [75]
0
0
Bardejov
Query!
Country [76]
0
0
Slovakia
Query!
State/province [76]
0
0
Nitra
Query!
Country [77]
0
0
Slovakia
Query!
State/province [77]
0
0
Nove Zamky
Query!
Country [78]
0
0
Slovenia
Query!
State/province [78]
0
0
Ljubljana
Query!
Country [79]
0
0
Taiwan
Query!
State/province [79]
0
0
Changhua
Query!
Country [80]
0
0
Taiwan
Query!
State/province [80]
0
0
Taichung
Query!
Country [81]
0
0
Taiwan
Query!
State/province [81]
0
0
Taipei
Query!
Country [82]
0
0
Thailand
Query!
State/province [82]
0
0
Bangkoknoi
Query!
Country [83]
0
0
Thailand
Query!
State/province [83]
0
0
Bangkok
Query!
Country [84]
0
0
Thailand
Query!
State/province [84]
0
0
Muang
Query!
Country [85]
0
0
Thailand
Query!
State/province [85]
0
0
Pathumwan
Query!
Country [86]
0
0
Thailand
Query!
State/province [86]
0
0
Ratchathewi
Query!
Country [87]
0
0
Ukraine
Query!
State/province [87]
0
0
Dnipropetrovsk
Query!
Country [88]
0
0
Ukraine
Query!
State/province [88]
0
0
Kiev
Query!
Country [89]
0
0
Ukraine
Query!
State/province [89]
0
0
Uzhgorod
Query!
Country [90]
0
0
Ukraine
Query!
State/province [90]
0
0
Vinnitsa
Query!
Country [91]
0
0
United Kingdom
Query!
State/province [91]
0
0
Birmingham
Query!
Country [92]
0
0
United Kingdom
Query!
State/province [92]
0
0
Leeds
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
UCB Pharma
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01921205
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
UCB Cares
Query!
Address
0
0
+1 877 822 9493
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01921205
Download to PDF