A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures

UCB

Status and phase: Completed; Phase 2

Conditions: Epilepsy

Treatments: Drug: Lacosamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00938431

2011-001558-27 (EudraCT Number)

SP0847

Details and patient eligibility

About

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).

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 1 month to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 5 patient groups

Lacosamide - Age 5 - 11 years

Experimental group

Description:

Cohort 1 (Age 5 - 11 years); up to 8 mg/kg/day

Treatment:

Drug: Lacosamide

Lacosamide - (Age 12 - 17 years)

Experimental group

Description:

Cohort 2 (Age 12 - 17 years); 12 mg/kg/day.

Treatment:

Drug: Lacosamide

Lacosamide (Age 2 - 4 years)

Experimental group

Description:

Cohort 3 (Age 2 - 4 years); 12 mg/kg/day.

Treatment:

Drug: Lacosamide

Lacosamide (Age 5 - 11 years)

Experimental group

Description:

Cohort 4 (Age 5 - 11 years); 12 mg/kg/day.

Treatment:

Drug: Lacosamide

Lacosamide (Age 1 month - < 2 years)

Experimental group

Description:

Cohort 5 (Age 1 month to \< 2 years); 12 mg/kg/day

Treatment:

Drug: Lacosamide