Clinical trial NCT00938431: A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
Official title: A Multicenter, Open-Label Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of Lacosamide (LCM) Oral Solution (Syrup) As Adjunctive Therapy In Children With Partial-Onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Keywords: Lacosamide
Vimpat
Children
Epilepsy
Seizures
Anti-epileptic
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 47
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the safety and pharmacokinetics of LCM syrup in children ages from 1 month to 17 years with uncontrolled partial seizures when added to 1 to 3 other antiepileptic drugs (AEDs).

Detailed description: Six subjects aged 5-11 (Cohort 1) were initially enrolled at the 8 mg/kg/day dose level. Upon completion of the study for these subjects, pharmacokinetic and safety data were analyzed to determine the target dose for the remaining subjects (either 8, 10 or 12 mg/kg/day). Depending on the selected target dose, four additional age-based cohorts of subjects were to be enrolled. LCM was increased 2 mg/kg/day per week until the target dose or maximum dose able to be tolerated was achieved.

Eligibility criteria: Inclusion Criteria:

* Subject is male or female between 1 month and 17 years of age inclusive
* Subject's Body Mass Index (BMI) is within the 5th to 95th percentile for his/her age group
* Subject has a diagnosis of epilepsy with partial-onset seizures
* Subject has been observed to have uncontrolled partial-onset seizures after an adequate course of treatment with at least 2 anti-epileptic drugs (AEDs) (concurrently or sequentially)
* Subject has been observed to have at least 2 countable seizures in the 4-week period prior to Screening
* Subject is on a stable dosage regimen of 1 to 3 AEDs

Exclusion Criteria:

* Subject is currently participating or has participated within the last 2 months in any study of an investigational drug or experimental device
* Subject with seizures that are uncountable due to clustering during the 8-week period prior to study entry
* Subject is on a ketogenic or other specialized diet
* Subject has a history of primary generalized epilepsy
* Subject has a history of status epilepticus within the 6-month period prior to Screening
* Subject is receiving concomitant treatment with felbamate or has received previous felbamate therapy within the last 6 months prior to Screening
* Subject has taken or is currently taking vigabatrin
* Subject is taking monoamine oxidase (MAO) inhibitors or narcotic analgesics
* Subject has a lifetime history of suicide attempt, or has suicidal ideation in the past 6 months

Primary outcomes:
measure: Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks)
timeFrame: 13 weeks
Secondary outcomes:
measure: Change in Seizure Frequency From Baseline to End of Treatment
timeFrame: From Baseline to End of Treatment (approximately 13 weeks)
measure: Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination
timeFrame: Visit 5 (Day 27/28) or Early Termination
measure: Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination
timeFrame: Visit 5 (Day 27/28) or Early Termination
measure: Plasma Ctrough Values for Lacosamide at Day 7
timeFrame: Day 7
measure: Plasma Ctrough Values for Lacosamide at Day 28
timeFrame: Day 28
measure: Plasma Ctrough Values for Lacosamide at Day 35
timeFrame: Day 35
measure: Plasma Ctrough Values for Lacosamide at Day 42
timeFrame: Day 42
measure: Plasma Ctrough Values for SPM 12809 at Day 7
timeFrame: Day 7
measure: Plasma Ctrough Values for SPM 12809 at Day 28
timeFrame: Day 28
measure: Plasma Ctrough Values for SPM 12809 at Day 35
timeFrame: Day 35
measure: Plasma Ctrough Values for SPM 12809 at Day 42
timeFrame: Day 42
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: 025
state: California
city: Washington
country: United States
facility: 002
state: District of Columbia
city: Tampa
country: United States
facility: 012
state: Florida
city: Wellington
country: United States
facility: 019
state: Florida
city: Saint Paul
country: United States
facility: 006
state: Minnesota
city: Kansas City
country: United States
facility: 008
state: Missouri
city: New Brunswick
country: United States
facility: 015
state: New Jersey
city: Durham
country: United States
facility: 005
state: North Carolina
city: Philadelphia
country: United States
facility: 001
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 016
state: Pennsylvania
city: Nashville
country: United States
facility: 004
state: Tennessee
city: Austin
country: United States
facility: 026
state: Texas
city: Houston
country: United States
facility: 022
state: Texas
city: Norfolk
country: United States
facility: 020
state: Virginia
city: Brussels
country: Belgium
facility: 201
city: Edegem
country: Belgium
facility: 200
city: Leuven
country: Belgium
facility: 202
city: Culiacan
country: Mexico
facility: 101
city: Guadalajara
country: Mexico
facility: 104
city: Monterrey
country: Mexico
facility: 105
city: San Luis Potosi
country: Mexico
facility: 103
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Winkler J, Schoemaker R, Stockis A. Population Pharmacokinetics of Adjunctive Lacosamide in Pediatric Patients With Epilepsy. J Clin Pharmacol. 2019 Apr;59(4):541-547. doi: 10.1002/jcph.1340. Epub 2018 Nov 14.