IV Lacosamide: The Safety of Intravenous Lacosamide

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• Patient or LAR must sign informed consent

• Diagnosis of partial onset currently uncontrolled

• Patient must have received anti-epileptic drug therapy prior to initiation

• Patient must have a medical condition in which parental administration is desireable

• Male or female

• Ages 4-35

Exclusion Criteria:

• Patient has participated in a study involving IV Lacosamide

• Patient has had an episode of status epilepticus in the last 3 months

• Drug history to lacosamide pregnant or lactating

• If of child bearing age, must have pregnancy test

• Patient has participated in an experimental drug study in last 30 days

• Patients with significant active hepatic or renal disease.

• Patients with known cardiac disease.