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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02477839
Ethics application status
Date submitted
13/05/2015
Date registered
23/06/2015
Date last updated
1/07/2021

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
Adenomatous Polyps 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Lacosamide
Other interventions - Placebo
Other interventions - blood or stool samples will be collected

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

Placebo comparator: Placebo - Matching placebo syrup

Normal subjects - blood or stool samples will be collected from people referred for screening colonoscopy

Colorectal cancer - blood or stool samples will be collected from people with colorectal cancer detected at colonoscopy or resection

Polyps <10mm and no high risk features - blood or stool samples will be collected from people with no polyps or low risk polyps (\<10mm, no villous component or dysplasia) detected at colonoscopy

Advanced Mucosal Neoplasia - blood or stool samples will be collected from people with AMN detected at resection

Sessile Serrated Adenoma - blood or stool samples will be collected from people with SSP detected at resection

non-colorectal neoplastic disease - Participants with disease that is not colorectal neoplasia. Analysis of this cohort is not a primary endpoint but the investigators will report assay positivity in this group on an opportunistic basis. This cohort will include patients diagnosed with, for example, inflammatory bowel disease or extracolonic cancer.


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

Other interventions: blood or stool samples will be collected
blood or stool samples will be collected
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 Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
Timepoint [1] 0 0
End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Primary outcome [2] 0 0
Participant Withdrawals Due to Adverse Events (AEs) During the Study
Timepoint [2] 0 0
From the Baseline Period (Day -7) to the End of Study Visit (up to 93 days)
Primary outcome [3] 0 0
Percentage of Participants With Adverse Events Reported Spontaneously by the Participant's Parent(s) and/or Legal Representative(s)/Caregiver(s) (in Accordance With Local Regulation) or Observed by the Investigator
Timepoint [3] 0 0
From the Baseline Period (Day -7) to the End of Study Visit (up to 93 days)
Primary outcome [4] 0 0
Demographics
Timepoint [4] 0 0
1 day
Primary outcome [5] 0 0
Level of methylated DNA in circulation
Timepoint [5] 0 0
5 years
Primary outcome [6] 0 0
Level of haemoglobin in stool
Timepoint [6] 0 0
5 years
Primary outcome [7] 0 0
Demographics
Timepoint [7] 0 0
1 day
Secondary outcome [1] 0 0
Absolute Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
Timepoint [1] 0 0
End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Secondary outcome [2] 0 0
Percent Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
Timepoint [2] 0 0
End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Secondary outcome [3] 0 0
Percentage of Participants Who Achieved 'Seizure-free' Status From All Seizure Types During the End-of-Maintenance (EOM) Period Video-EEG
Timepoint [3] 0 0
During the End-of-Maintenance Period (Day 24 to Day 27)
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved 'Seizure-free' Status From Partial-onset Seizure Types Only During the End-of-Maintenance (EOM) Period Video-EEG
Timepoint [4] 0 0
During the End-of-Maintenance Period (Day 24 to Day 27)
Secondary outcome [5] 0 0
Percentage of Participants Experiencing a >=25% to <50% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
Timepoint [5] 0 0
End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Secondary outcome [6] 0 0
Percentage of Participants Experiencing a 50% to 75% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
Timepoint [6] 0 0
End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Secondary outcome [7] 0 0
Percentage of Participants Experiencing a >75% Reduction in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
Timepoint [7] 0 0
End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Secondary outcome [8] 0 0
Percentage of Participants Experiencing no Change in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures (Between <25% Reduction and <25% Increase) From EOB Period Video-EEG to EOM Period Video-EEG
Timepoint [8] 0 0
End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
Secondary outcome [9] 0 0
Percentage of Participants Experiencing an Increase in Average Daily Frequency (ADF) of Electrographic Partial-onset Seizures of >=25% From End-of-Baseline (EOB) Period Video-EEG to End-of-Maintenance (EOM) Period Video-EEG
Timepoint [9] 0 0
End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)

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
Sex
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 Syndrome, 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/05/2020
Sample size
Target
Accrual to date
Final
255
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
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
Country [3] 0 0
United States of America
State/province [3] 0 0
Nevada
Country [4] 0 0
United States of America
State/province [4] 0 0
New Hampshire
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Argentina
State/province [6] 0 0
Córdoba
Country [7] 0 0
Brazil
State/province [7] 0 0
Passo Fundo
Country [8] 0 0
Brazil
State/province [8] 0 0
Porto Alegre
Country [9] 0 0
Brazil
State/province [9] 0 0
São Paulo
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Plovdiv
Country [11] 0 0
China
State/province [11] 0 0
Beijing
Country [12] 0 0
China
State/province [12] 0 0
Changchun
Country [13] 0 0
China
State/province [13] 0 0
Chongqing
Country [14] 0 0
China
State/province [14] 0 0
Nanchang
Country [15] 0 0
China
State/province [15] 0 0
Shanghai
Country [16] 0 0
China
State/province [16] 0 0
Shenzhen
Country [17] 0 0
Croatia
State/province [17] 0 0
Osijek
Country [18] 0 0
Croatia
State/province [18] 0 0
Rijeka
Country [19] 0 0
Croatia
State/province [19] 0 0
Zagreb
Country [20] 0 0
Czechia
State/province [20] 0 0
Ostrava-Poruba
Country [21] 0 0
France
State/province [21] 0 0
Marseille
Country [22] 0 0
France
State/province [22] 0 0
Rennes
Country [23] 0 0
France
State/province [23] 0 0
Strasbourg
Country [24] 0 0
Georgia
State/province [24] 0 0
Tbilisi
Country [25] 0 0
Greece
State/province [25] 0 0
Athens
Country [26] 0 0
Hungary
State/province [26] 0 0
Budapest
Country [27] 0 0
Israel
State/province [27] 0 0
Petah tikva
Country [28] 0 0
Italy
State/province [28] 0 0
Genova
Country [29] 0 0
Italy
State/province [29] 0 0
Messina
Country [30] 0 0
Italy
State/province [30] 0 0
Milano
Country [31] 0 0
Italy
State/province [31] 0 0
Napoli
Country [32] 0 0
Italy
State/province [32] 0 0
Roma
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
Mexico
State/province [34] 0 0
Aguascalientes
Country [35] 0 0
Mexico
State/province [35] 0 0
Chihuahua
Country [36] 0 0
Mexico
State/province [36] 0 0
Culiacán
Country [37] 0 0
Mexico
State/province [37] 0 0
Guadalajara
Country [38] 0 0
Mexico
State/province [38] 0 0
Mexico
Country [39] 0 0
Mexico
State/province [39] 0 0
Monterrey
Country [40] 0 0
Moldova, Republic of
State/province [40] 0 0
Chisinau
Country [41] 0 0
Philippines
State/province [41] 0 0
Cebu
Country [42] 0 0
Philippines
State/province [42] 0 0
Manila
Country [43] 0 0
Philippines
State/province [43] 0 0
Quezon City
Country [44] 0 0
Poland
State/province [44] 0 0
Kraków
Country [45] 0 0
Portugal
State/province [45] 0 0
Lisbon
Country [46] 0 0
Romania
State/province [46] 0 0
Bucuresti
Country [47] 0 0
Romania
State/province [47] 0 0
Iasi
Country [48] 0 0
Romania
State/province [48] 0 0
Sibiu
Country [49] 0 0
Romania
State/province [49] 0 0
Timisoara
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Kemerovo
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Nizhny Novgorod
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Novosibirsk
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Omsk
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Perm
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Smolensk
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Tomsk
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Ulyanovsk
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Yekaterinburg
Country [59] 0 0
Serbia
State/province [59] 0 0
Belgrade
Country [60] 0 0
Serbia
State/province [60] 0 0
Novi Sad
Country [61] 0 0
Slovakia
State/province [61] 0 0
Bratislava
Country [62] 0 0
Taiwan
State/province [62] 0 0
Taipei
Country [63] 0 0
Thailand
State/province [63] 0 0
Bangkok
Country [64] 0 0
Thailand
State/province [64] 0 0
Pathum Wan
Country [65] 0 0
Ukraine
State/province [65] 0 0
Dnipropetrovs'k
Country [66] 0 0
Ukraine
State/province [66] 0 0
Dnipro
Country [67] 0 0
Ukraine
State/province [67] 0 0
Ivano-Frankivs'k
Country [68] 0 0
Ukraine
State/province [68] 0 0
Kiev
Country [69] 0 0
Ukraine
State/province [69] 0 0
Uzhgorod
Country [70] 0 0
Ukraine
State/province [70] 0 0
Vinnytsia

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02477839