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: 22 November 2021
• Main ID: EUCTR2012-005012-26-Outside-EU/EEA
• Date of registration: 18/06/2014
• 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
• Recruitment status: NA
• 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, Czechia, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Moldova, Republic of, Montenegro, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, 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:
- 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
- Subject has completed the Transition Period of SP0967 [NCT02477839] or SP0969 [NCT01921205] for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy
- Subject is expected to benefit from participation, in the opinion of the investigator
- 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 aged 1 month to =17 years
- 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:
- Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
- Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for SP0967 or SP0969, or is experiencing an ongoing serious adverse event (SAE)
- 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
- 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


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: 21.0 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)

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

Primary end point(s): 1. Percentage of participants with treatment-emergent adverse events (TEAEs)
2. Percentage of participants with serious TEAEs
3. Percentage of participants with TEAEs leading to study discontinuation

Timepoint(s) of evaluation of this end point: 1. - 3. From Week 0 to the End of Safety Follow-Up (approximately 104 weeks)

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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: From Week 0 to End of Treatment Period (up to Week 96)

Secondary end point(s): Percentage of seizure-free days during the study

Secondary ID(s)

EP0034

NCT01964560

2012-005012-26-BE

Source(s) of Monetary Support

UCB Biosciences Inc.