IV Lacosamide: The Safety of Intravenous Lacosamide

September 21, 2020 updated by: James W. Wheless, Le Bonheur Children's Hospital
The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • LeBonheur Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
IV Lacosamide administered (intravenously) over 30 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1 mg/ kg and 2.9 mg/kg over 30 minutes.
Drug: IV Lacosamide
Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy.
Other Names:
  • Vimpat
Active Comparator: Group B
IV Lacosamide to be administered (intravenously) over 15 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1mg/kg, 2,4 mg/kg
Drug: IV Lacosamide
Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy.
Other Names:
  • Vimpat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events (TEAEs), reported or observed.
Time Frame: 2 years
Bradycardia, hypotension, fatigue, nausea, somnolence.
2 years
Measure post-infusion lacosamide plasma concentrations
Time Frame: 2 years
Serum lacosamide level drawn from the arm opposite intravenous infusion
2 years
Measure changes in EKG, PR interval
Time Frame: 2 years
PR interval changes measured in seconds
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Le Bonheur Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

November 8, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Actual)

September 22, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-00570-FB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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