Estudio de extensión a largo plazo, multicéntrico, abierto, para investigar la eficacia y seguridad de lacosamida como terapia adyuvante en sujetos pediátricos con epilepsia con crisis de inicio parcial.

CompletadoFase 3ClinicalTrials.gov

ID: NCT01964560Tipo: INTERVENTIONALInicio: 13 de ago de 2014Fin estimado: 13 de abr de 2022

Resumen

El propósito de este estudio es evaluar la seguridad, tolerabilidad y eficacia a largo plazo de lacosamida (LCM) en sujetos pediátricos.

Elegibilidad

Edad mínima: 1 MonthEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Lacosamide

Pharmaceutical form: oral solution Concentration: 1 mg/kg - 6 mg/kg BID (2 mg/kg/day - 12 mg/ kg/day) Route of administration: oral use

drug

Lacosamide

Pharmaceutical form: tablet Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day) Route of administration: oral use

Ubicaciones

Ep0034 143

Ciudad Autonoma de Buenos AIRE, Argentina

Ep0034 142

Córdoba, Argentina

Patrocinadores

PrincipalUCB BIOSCIENCES, Inc.

ColaboradorUCB Biopharma SRL

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