The Safety of Intravenous Lacosamide

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Le Bonheur Children's Hospital
• Treatments: Lacosamide

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.