Clinical trial NCT00832884: The Safety of Intravenous Lacosamide
Official title: IV Lacosamide: The Safety of Intravenous Lacosamide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Keywords: partial
onset
epilepsy
pediatric
lacosamide
partial onset epilepsy
vimpat
Lead sponsor: Le Bonheur Children's Hospital
Sponsor class: OTHER
First posted: 2009-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the safety of IV Lacosamide given as a rapid infusion.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: LeBonheur Children's Medical Center
state: Tennessee
Study officials:
affiliation: LeBonheur Children's Medical Center
name: James W Wheless, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/j.1528-1167.2007.01317.x. Epub 2007 Sep 19.
citation: 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. doi: 10.1016/s0920-1211(00)00171-6.