A CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS AN ADD ON THERAPY IN CHILDREN WITH EPILEPSY WITH PARTIAL ONSET SEIZURES

• Register: EUCTR
• Last refreshed on: 2 March 2015
• Main ID: EUCTR2012-005012-26-RO
• Date of registration: 13/05/2014
• 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: 11/11/2014
• Target sample size: 500
• Recruitment status: Authorised-recruitment may be ongoing or finished
• 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

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Estonia, European Union, Hungary, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Poland, Romania, Russian Federation, Serbia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United States

Contacts

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB BIOSCIENCES GmbH

• Name: Clin Trial Reg & Results Disclosure
• 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.
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 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. Subjects with a major protocol deviation during the primary study (or a deviation related to enrollment criteria for primary study).
5. 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 Conference 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Epilepsy with Partial Onset Seizures
MedDRA version: 17.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders

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)

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

Secondary Objective: To assess the efficacy of lacosamide during long-term exposure in pediatric subjects

Main Objective: To assess the long-term safety and tolerability of lacosamide in pediatric subjects

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)

2012-005012-26-BE

EP0034

Source(s) of Monetary Support

UCB Biosciences Inc.