The Safety of Intravenous Lacosamide

Phase 4

Completed

• Conditions: Epilepsy
• Interventions: Drug: Lacosamide

• Registration Number: NCT00832884
• Lead Sponsor: Le Bonheur Children's Hospital

Brief Summary

To evaluate the safety of IV Lacosamide in children with partial-onset epilepsy, ages 4-35 years old, inclusive, who are either unable to take oral medication or require intravenous administration of IV Lacosamide.

Detailed Description

Lacosamide tablets and intravenous formulations were both approved in the United States in the fall of 2008. Lacosamide is indicated for use as adjunctive therapy in the treatment of partial onset seizure disorder in patients' age seventeen years and older. A parenteral dosage form of Lacosamide is desirable for patients who are temporarily unable to take medication orally. The objective of this study is to evaluate the safety of IV Lacosamide in children with epilepsy, ages 4 to 35 years, who are either unable to take oral medication, or whom parenteral administration of IV Lacosamide is desirable.

Study Timeline

• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Study First Posted: 2009-01-30
• Study Start: 2010-03
• Primary Completion: 2012-05
• Study Completion: 2012-11
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients must have a diagnosis of epilepsy and have received anti-epileptic drug therapy prior to initiation of IV Lacosamide
• Patients must have a medical condition in which the parenteral administration of Lacosamide is desirable.
• Patients may be male or female.
• Patients must be 4 years of age or older, and less than age 35 years.
• Patient or his / her legally authorized representative must sign an informed consent form prior to any study specific procedures.

Exclusion Criteria

• Patients will be excluded from entry into the study if any of the following are true:
• Patient has previously participated in any other intravenous Lacosamide study.
• Patient has status epilepticus within the last 3 months.
• Patient has a history of drug allergy to Lacosamide.
• Patient is pregnant.
• Patient has taken experimental drug within last 30 days.
• Patient with significant hepatic or renal disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1A	Lacosamide	Lacosamide, IV, 50 mg, once, 30 minutes
Group 2A	Lacosamide	Lacosamide, IV, 100 mg, once, 30 min
Group 3A	Lacosamide	Lacosamide, IV, 150 mg, once, 30 min
Group 4A	Lacosamide	Lacosamide, IV, 200 mg, once, 30 min
Group 1B	Lacosamide	Lacosamide, IV, 50 mg, once, 15 min
Group 2B	Lacosamide	Lacosamide, IV, 100 mg, once, 15 min
Group 3B	Lacosamide	Lacosamide, IV, 150 mg, once, 15 min
Group 4B	Lacosamide	Lacosamide, IV, 200 mg, once, 15 min

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of IV Lacosamide given as a rapid infusion.	one year	The safety of IV Lacosamide will be assessed in patients in whom parental administration of Lacosamide is warranted.

Trial Locations

Locations (1)

LeBonheur Children's Medical Center; 🇺🇸 Memphis, Tennessee, United States