IV Lacosamide: The Safety of Intravenous Lacosamide

Epilepsy Clinical Trial

Official title:

IV Lacosamide: The Safety of Intravenous Lacosamide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981447
• Other study ID #: 09-00570-FB
• Status: Completed
• Phase: Phase 3
• Start date: April 2010
• Est. completion date: August 2012

Study information

• Verified date: September 2020
• Source: Le Bonheur Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

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

Locations

Country	Name	City	State
United States	Lebonheur Children's Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Le Bonheur Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

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