Clinical trial NCT02710890: Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children.
Official title: A Multicenter, Open-Label Study to Investigate the Safety and Tolerability of Intravenous Lacosamide in Children (>= 1 Month to < 17 Years of Age) With Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
pediatric
intravenous
children
Lacosamide
VIMPAT®
seizure
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2016-03-17
Enrollment: 103
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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:

  1. 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,
  2. Prescription lacosamide (RxL) subject: Subject is currently receiving prescribed oral LCM from commercial supply (eg, VIMPAT) as adjunctive or monotherapy; OR,
  3. 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:

  1. Subject has been administered LCM for the treatment of epilepsy for at least 2 weeks prior to Screening; AND
  2. 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With at Least One Adverse Event Reported Spontaneously by the Participant/or Caregiver (Including Parent/Legal Guardian) or Observed by the Investigator During the Study
timeFrame: From Screening Period (Day -7 to Day -1) up to the End-of-Study Period (up to Day 37)
measure: Percentage of Participants That Withdrew Due to Adverse Events During the Study
timeFrame: From Screening Period (Day -7 to Day -1) up to the End-of-Study Period (up to Day 37)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Ep0060 003
state: Alabama
city: Little Rock
country: United States
facility: Ep0060 010
state: Arkansas
city: Loxahatchee Groves
country: United States
facility: Ep0060 008
state: Florida
city: Saint Paul
country: United States
facility: Ep0060 009
state: Minnesota
city: Henderson
country: United States
facility: Ep0060 014
state: Nevada
city: New Brunswick
country: United States
facility: Ep0060 002
state: New Jersey
city: Akron
country: United States
facility: Ep0060 006
state: Ohio
city: Cincinnati
country: United States
facility: Ep0060 011
state: Ohio
city: Dallas
country: United States
facility: Ep0060 005
state: Texas
city: San Antonio
country: United States
facility: Ep0060 007
state: Texas
city: Budapest
country: Hungary
facility: Ep0060 400
city: Debrecen
country: Hungary
facility: Ep0060 401
city: Messina
country: Italy
facility: Ep0060 503
city: Roma
country: Italy
facility: Ep0060 505
city: Verona
country: Italy
facility: Ep0060 502
city: Kraków
country: Poland
facility: Ep0060 701
city: Dnipro
country: Ukraine
facility: Ep0060 224
city: Dnipro
country: Ukraine
facility: Ep0060 225
city: Ivano-Frankivs'k
country: Ukraine
facility: Ep0060 220
city: Kiev
country: Ukraine
facility: Ep0060 221
city: Kiev
country: Ukraine
facility: Ep0060 222
city: Kiev
country: Ukraine
facility: Ep0060 226
city: Vinnytsia
country: Ukraine
facility: Ep0060 223
Study officials:
affiliation: +1 8445992273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Farkas MK, Beller C, Bozorg A, McClung C, Roebling R, Yates T, Yuen N, Makedonska I. Safety and tolerability of short-term infusions of intravenous lacosamide in pediatric patients with epilepsy: An open-label, phase 2/3 trial. Epilepsia Open. 2023 Mar;8(1):146-153. doi: 10.1002/epi4.12682. Epub 2023 Jan 18.