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: NCT00832884
• Other study ID #: 00570-FB
• Status: Completed
• Phase: Phase 4
• Start date: March 2010
• Est. completion date: November 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

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.

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.

Other known NCT identifiers

• NCT00720863

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Lacosamide
0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes. 0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes

Locations

Country	Name	City	State
United States	LeBonheur Children's Medical Center	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Le Bonheur Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bialer M, Johannessen SI, Kupferberg HJ, Levy RH, Loiseau P, Perucca E. Progress report on new antiepileptic drugs: a summary of the Fifth Eilat Conference (EILAT V). Epilepsy Res. 2001 Jan;43(1):11-58. — View Citation

Biton V, Rosenfeld WE, Whitesides J, Fountain NB, Vaiciene N, Rudd GD. Intravenous lacosamide as replacement for oral lacosamide in patients with partial-onset seizures. Epilepsia. 2008 Mar;49(3):418-24. Epub 2007 Sep 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety of IV Lacosamide given as a rapid infusion.	The safety of IV Lacosamide will be assessed in patients in whom parental administration of Lacosamide is warranted.	one year

External Links

•   Study site website