World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 9 May 2022
Main ID:  EUCTR2012-005012-26-BG
Date of registration: 19/05/2014
Prospective Registration: Yes
Primary sponsor: UCB Biosciences Inc.
Public title: A CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS AN ADD ON THERAPY IN CHILDREN WITH EPILEPSY WITH PARTIAL ONSET SEIZURES
Scientific title: A MULTICENTER, OPEN-LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN PEDIATRIC SUBJECTS WITH EPILEPSY WITH PARTIAL ONSET SEIZURES
Date of first enrolment: 16/07/2014
Target sample size: 500
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005012-26
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Argentina Australia Belgium Brazil Bulgaria China Colombia Croatia
Czech Republic Denmark Estonia Finland France Georgia Germany Greece
Hungary Israel Italy Japan Korea, Republic of Latvia Lithuania Mexico
Moldova, Republic of Montenegro Philippines Poland Portugal Romania Russian Federation Serbia
Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand
Turkey Ukraine United Kingdom United States
Contacts
Name: Clin Trial Reg & Results Disclosure   
Address:  Alfred-Nobel-Strasse 10 D-40789 Monheim Germany
Telephone:
Email: clinicaltrials@ucb.com
Affiliation:  UCB BIOSCIENCES GmbH
Name: Clin Trial Reg & Results Disclosure   
Address:  Alfred-Nobel-Strasse 10 D-40789 Monheim Germany
Telephone:
Email: clinicaltrials@ucb.com
Affiliation:  UCB BIOSCIENCES GmbH
Key inclusion & exclusion criteria
Inclusion criteria:
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors.
2. Subject has completed the Transition Period of SP0967 or SP0969 for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy.
3. Subject is expected to benefit from participation, in the opinion of the investigator.
4. 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.
5. Subject is male or female aged 1 month to = 17 years.
6. Subject has a diagnosis of epilepsy with partial-onset seizures
Are the trial subjects under 18? yes
Number of subjects for this age range: 500
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide.
2. Subject meets a mandatory withdrawal criterion (ie, MUST withdrow criterion) for SP0967 or SP0969 or is experiencing an ongoing serious AE (SAE).
3. For subjects =6 years of age, subject 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 Visit 1.
4. 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 the International Council on Harmonisation [ICH] guidance defined as those that result in a failure rate <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 World Health Organization 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.
5. Subject has >2x the upper limit of normal (ULN) of any of the following: ALT, AST, ALP, or >ULN total bilirubin (=1.5xULN total bilirubin if known Gilbert’s syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert’s syndrome (ie, direct bilirubin <35%). For enrolled subjects with a Baseline result >ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic Case Report form (eCRF).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Epilepsy with Partial Onset Seizures
MedDRA version: 21.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: Vimpat
Product Name: Lacosamide
Pharmaceutical Form: Syrup
INN or Proposed INN: LACOSAMIDE
CAS Number: 175481-36-4
Current Sponsor code: SPM927
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: Vimpat
Product Name: Lacosamide
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LACOSAMIDE
CAS Number: 175481-36-4
Current Sponsor code: SPM927
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Vimpat
Product Name: Lacosamide
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LACOSAMIDE
CAS Number: 175481-36-4
Current Sponsor code: SPM927
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: To assess the long-term safety and tolerability of lacosamide in pediatric subjects
Secondary Objective: To assess the efficacy of lacosamide during long-term exposure in pediatric subjects
Primary end point(s): 1) Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) during the study
2) Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) leading to discontinuation from the study
Timepoint(s) of evaluation of this end point: 1) From Baseline to End of Treatment period
2) From Baseline to End of Treatment
Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: 1) End of Year 1 of the Study (approximately 52 weeks)
2) End of Year 2 of the Study (approximately 96 weeks)
Secondary end point(s): 1) Percentage of seizure free days at the end of Year 1;
2) Percentage of seizure free days at end of Year 2
Secondary ID(s)
EP0034
2012-005012-26-BE
Source(s) of Monetary Support
UCB Biosciences Inc.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 16/07/2014
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history