NCT01981447

IV Lacosamide: The Safety of Intravenous Lacosamide

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Le Bonheur Children's Hospital · Academic / Other
• Sex: All
• Age: 4 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

The objective of this study is to evaluate the safety of IV Lacosamide in children ages 4 years to 35 years, inclusive who are unable to take oral medications or require parenteral administration of IV Lacosamide Occasionally, patients over the age of 20 are seen at LeBonheur Children's Hospital due to the complexity of their condition, or due to a long relationship with their physician. These are exceptions which are reviewed on a case by case basis and are approved by the hospital administrator for admissions and outpatient testing.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	IV Lacosamide	Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy.

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2013-11-11
• Last updated: 2020-09-22

Locations

1 site across 1 country: United States