A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures

Phase 3CompletedNCT01964560

UCB BIOSCIENCES, Inc.540 enrolled

Overview

The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

540

Conditions

Epilepsy

Interventions

LacosamideDRUG

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

LacosamideDRUG

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

Eligibility

Sex: ALLMin age: 1 MonthMax age: 17 Years

Medical Language ↔ Plain English

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 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

Locations (141)

Outcomes

Primary Outcomes

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.

Time frame: From Week 0 to the End of Safety Follow-Up (up to Week 104)

Percentage of Participants With Serious TEAEs

A serious adverse event (SAE) must meet 1 or more of the following criteria: • Death, • Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), • Significant or persistent disability/incapacity, • Congenital anomaly/birth defect (including that occurring in a fetus), • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious., • Initial inpatient hospitalization or prolongation of hospitalization. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.

Time frame: From Week 0 to the End of Safety Follow-Up (up to Week 104)

Percentage of Participants With TEAEs Leading to Study Discontinuation

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to study discontinuation. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.

Time frame: From Week 0 to the End of Safety Follow-Up (up to Week 104)

Secondary Outcomes

Data from ClinicalTrials.gov

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Ep0034 638

Birmingham, Alabama, United States

Ep0034 105

Orlando, Florida, United States

Ep0034 117

Tampa, Florida, United States

Ep0034 124

Lexington, Kentucky, United States

Ep0034 115

Henderson, Nevada, United States

Ep0034 120

Lebanon, New Hampshire, United States

Ep0034 102

Charlotte, North Carolina, United States

Ep0034 640

Springfield, Oregon, United States

Ep0034 129

Dallas, Texas, United States

Ep0034 630

San Antonio, Texas, United States

...and 131 more locations