IV Lacosamide: The Safety of Intravenous Lacosamide

Le Bonheur Children's Hospital

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: IV Lacosamide

Study type: Interventional

Funder types: Other

Identifiers

NCT01981447

09-00570-FB

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 4 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group A

Active Comparator group

Description:

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.

Treatment:

Drug: IV Lacosamide

Group B

Active Comparator group

Description:

IV Lacosamide to be administered (intravenously) over 15 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1mg/kg, 2,4 mg/kg

Treatment:

Drug: IV Lacosamide