Status:
COMPLETED
A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
1-17 years
Phase:
PHASE2
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 antiepile...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00938431
Start Date
November 1 2009
End Date
August 1 2014
Last Update
March 19 2019
Active Locations (21)
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1
025
Sacramento, California, United States
2
002
Washington D.C., District of Columbia, United States
3
012
Tampa, Florida, United States
4
019
Wellington, Florida, United States