Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children.

Completed · Phase 2/Phase 3

Conditions studied: Epilepsy

In brief

EP0060 is a multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) Lacosamide (LCM) in pediatric subjects \>= 1 month to \< 17 years of age with epilepsy.

Key facts

Study ID: NCT02710890
Run by: UCB BIOSCIENCES, Inc.
People needed: 103
Starts: 2017-05-30
Expected to finish: 2019-06-28
Last updated by the study team: 2023-02-23

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female from >=1 month to <17 years of age
Subject has a diagnosis of epilepsy with partial-onset seizures or primary generalized tonic-clonic seizures
Subject meets 1 of the following criteria:
Open-label lacosmide (OLL) subject: Subject is currently receiving oral lacosmide (LCM) as adjunctive or monotherapy as participants in an open label long-term study (SP848, EP0034, or other pediatric study); OR,
Prescription lacosamide (RxL) subject: Subject is currently receiving prescribed oral LCM from commercial supply (eg, VIMPAT) as adjunctive or monotherapy; OR,
Initiating intravenous lacosamide (IIL) subject: Subject is not currently receiving LCM and will receive intravenous (iv) LCM as adjunctive treatment in EP0060. Initiation of LCM monotherapy is not permitted in IIL subjects.
Subject is an OLL or RxL subject and meets both of the following criteria:
Subject has been administered LCM for the treatment of epilepsy for at least 2 weeks prior to Screening; AND
Subject has been administered (OLL) or prescribed (RxL) oral LCM at a dose of 2 mg/kg/day to 12 mg/kg/day (for subjects <50 kg) or 100 mg/day to 600 mg/day (for subjects >=50 kg). Open-label study drug LCM (OLL) or prescribed oral LCM dose (RxL) must be stable for at least 3 days prior to first LCM infusion; OR,
Subject is an ILL subject and is on a stable dosage regimen of at least 1 antiepileptic drug (AED). The daily dosage regimen of concomitant AED therapy must be kept constant for a period of at least 2 weeks prior to Screening.
Subject is an acceptable candidate for venipuncture and iv infusion
Subject is, in the opinion of the investigator, able to comply with all study requirements. Subject (or parent[s] or legal representative) is willing to comply with all study requirements
Subject weighs >=4 kg

You may not qualify if…

Subject has previously received intravenous (iv) lacosamide (LCM) in this study
Subject has any medical, neurological, or psychiatric condition that, in the opinion of the investigator, could jeopardize the subject's health or compromise the subject's ability to participate in EP0060
Subject has clinically significant hypotension or bradycardia in the opinion of the investigator
Subject >=6 years of age 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 positive responses ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
For open-label lacosamide (OLL) subjects, enrollment in EP0060 is not permitted if any of the following additional criteria are met:
Subject has any ongoing Adverse Event (AE) in their long-term, open-label study that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate EP0060 or the subject meets any of the criteria for required withdrawal from the long-term open-label study
For prescription lacosamide (RxL) and initiating intravenous lacosamide (IIL) subjects, enrollment in EP0060 is not permitted if any of the following additional criteria are met:
Subject has a medical condition that could reasonably be expected to interfere with drug absorption distribution, metabolism, or excretion
Subject is a female of childbearing potential and does not practice an acceptable method of contraception for the duration of participation in EP0060
Subject has creatinine clearance less than 30 mL/min
Subject has a clinically relevant electrocardiogram (ECG) abnormality, in the opinion of the principal investigator (ie, second or third degree heart block at rest or a QT prolongation greater than 450 ms)
Subject has hemodynamically significant heart disease (eg, heart failure)
Subject has an arrhythmic heart condition requiring medical therapy, known cardiac sodium channelopathy, such as Brugada syndrome
Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias
Subject has an acute or subacutely progressive central nervous system disease.
Subject has epilepsy secondary to a progressing cerebral disease or any other progressive or neurodegenerative disease (malignant brain tumor or Rasmussen syndrome)
Lacosamide is intended for treatment of generalized convulsive status epilepticus
Subject has diagnosis of Dravet's syndrome
For IIL subjects, enrollment in EP0060 is not permitted if the following additional criterion is met:
Subject has been treated with LCM within the last 3 months prior to Screening

Where it is running

Ep0060 003 — Birmingham, Alabama, United States
Ep0060 010 — Little Rock, Arkansas, United States
Ep0060 008 — Loxahatchee Groves, Florida, United States
Ep0060 009 — Saint Paul, Minnesota, United States
Ep0060 014 — Henderson, Nevada, United States
Ep0060 002 — New Brunswick, New Jersey, United States
Ep0060 006 — Akron, Ohio, United States
Ep0060 011 — Cincinnati, Ohio, United States
Ep0060 005 — Dallas, Texas, United States
Ep0060 007 — San Antonio, Texas, United States
Ep0060 400 — Budapest, Hungary
Ep0060 401 — Debrecen, Hungary
Ep0060 503 — Messina, Italy
Ep0060 505 — Roma, Italy
Ep0060 502 — Verona, Italy
Ep0060 701 — Krakow, Poland
Ep0060 224 — Dnipro, Ukraine
Ep0060 225 — Dnipro, Ukraine
Ep0060 220 — Ivano-Frankivsk, Ukraine
Ep0060 221 — Kiev, Ukraine
Ep0060 222 — Kiev, Ukraine
Ep0060 226 — Kiev, Ukraine
Ep0060 223 — Vinnytsia, Ukraine

Full record on ClinicalTrials.gov

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