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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Lacosamide

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