Skip to main content
OpenTrials
Completed

NCT Number: NCT01981447

IV Lacosamide: The Safety of Intravenous Lacosamide

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lebonheur Children's Hospital

Memphis, Tennessee, 38103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IV Lacosamide

Drug

Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy.

Other names: Vimpat

Primary outcomes

  1. Number of participants with treatment-related adverse events (TEAEs), reported or observed.

    Time frame: 2 years

    Bradycardia, hypotension, fatigue, nausea, somnolence.

  2. Measure post-infusion lacosamide plasma concentrations

    Time frame: 2 years

    Serum lacosamide level drawn from the arm opposite intravenous infusion

  3. Measure changes in EKG, PR interval

    Time frame: 2 years

    PR interval changes measured in seconds

Sponsors and collaborators

Lead sponsor

Le Bonheur Children's Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 11, 2013
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.