Main
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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:
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EUCTR |
Last refreshed on:
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2 May 2022 |
Main ID: |
EUCTR2012-005012-26-DE |
Date of registration:
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26/08/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS AN ADD ON THERAPY IN CHILDREN WITH EPILEPSY WITH PARTIAL ONSET SEIZURES
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Scientific title:
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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:
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20/11/2015 |
Target sample size:
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500 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005012-26 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Brazil
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Bulgaria
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China
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Colombia
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Croatia
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Czech Republic
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Denmark
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Estonia
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Finland
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France
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Georgia
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Germany
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Greece
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Hungary
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Israel
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Italy
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Korea, Republic of
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Latvia
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Lithuania
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Mexico
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Moldova, Republic of
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Montenegro
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Poland
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Portugal
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Romania
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Russian Federation
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Serbia
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Slovakia
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Slovenia
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Spain
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Sweden
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Taiwan
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Thailand
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Clin Trial Reg & Results Disclosure
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Address:
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Alfred-Nobel-Strasse 10
D-40789
Monheim
Germany |
Telephone:
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Email:
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clinicaltrials@ucb.com |
Affiliation:
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UCB BIOSCIENCES GmbH |
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Name:
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Clin Trial Reg & Results Disclosure
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Address:
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Alfred-Nobel-Strasse 10
D-40789
Monheim
Germany |
Telephone:
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Email:
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clinicaltrials@ucb.com |
Affiliation:
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UCB BIOSCIENCES GmbH |
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Key inclusion & exclusion criteria
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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 withdraw 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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Epilepsy with Partial Onset Seizures MedDRA version: 20.0
Level: PT
Classification code 10015037
Term: Epilepsy
System Organ Class: 10029205 - Nervous system disorders
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Intervention(s)
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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-
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Primary Outcome(s)
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Main Objective: To assess the long-term safety and tolerability of lacosamide in pediatric subjects
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Timepoint(s) of evaluation of this end point: 1) From Baseline to End of Treatment period 2) From Baseline to End of Treatment
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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
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Secondary Objective: To assess the efficacy of lacosamide during long-term exposure in pediatric subjects
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Secondary Outcome(s)
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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)
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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
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Secondary ID(s)
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2012-005012-26-BE
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EP0034
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Source(s) of Monetary Support
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UCB Biosciences Inc.
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Ethics review
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Status: Approved
Approval date: 20/11/2015
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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