The Safety of Intravenous Lacosamide

Completed · Phase 4

Conditions studied: Epilepsy

In brief

To evaluate the safety of IV Lacosamide in children with partial-onset epilepsy, ages 4-35 years old, inclusive, who are either unable to take oral medication or require intravenous administration of IV Lacosamide.

Key facts

Study ID

NCT00832884

Run by

Le Bonheur Children's Hospital

People needed

40

Starts

2010-03-01

Expected to finish

2012-11-01

Last updated by the study team

2020-09-22

Who can join

Age: 4 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have a diagnosis of epilepsy and have received anti-epileptic drug therapy prior to initiation of IV Lacosamide
• Patients must have a medical condition in which the parenteral administration of Lacosamide is desirable.
• Patients may be male or female.
• Patients must be 4 years of age or older, and less than age 35 years.
• Patient or his / her legally authorized representative must sign an informed consent form prior to any study specific procedures.

You may not qualify if…

• Patients will be excluded from entry into the study if any of the following are true:
• Patient has previously participated in any other intravenous Lacosamide study.
• Patient has status epilepticus within the last 3 months.
• Patient has a history of drug allergy to Lacosamide.
• Patient is pregnant.
• Patient has taken experimental drug within last 30 days.
• Patient with significant hepatic or renal disease.

Where it is running

• LeBonheur Children's Medical Center — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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