A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
Completed · Phase 2
Conditions studied: Epilepsy
In brief
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).
Key facts
- Study ID
- NCT00938431
- Run by
- UCB Pharma
- People needed
- 47
- Starts
- 2009-11-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2019-03-19
Who can join
Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 025 — Sacramento, California, United States
- 002 — Washington D.C., District of Columbia, United States
- 012 — Tampa, Florida, United States
- 019 — Wellington, Florida, United States
- 006 — Saint Paul, Minnesota, United States
- 008 — Kansas City, Missouri, United States
- 015 — New Brunswick, New Jersey, United States
- 005 — Durham, North Carolina, United States
- 001 — Philadelphia, Pennsylvania, United States
- 016 — Pittsburgh, Pennsylvania, United States
- 004 — Nashville, Tennessee, United States
- 026 — Austin, Texas, United States
- 022 — Houston, Texas, United States
- 020 — Norfolk, Virginia, United States
- 201 — Brussels, Belgium
- 200 — Edegem, Belgium
- 202 — Leuven, Belgium
- 101 — Culiacán, Mexico
- 104 — Guadalajara, Mexico
- 105 — Monterrey, Mexico
- 103 — San Luis Potosí City, Mexico
Full record on ClinicalTrials.gov
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