The Safety of Intravenous Lacosamide

• To evaluate the safety of IV Lacosamide in children with epilepsy, ages 4-20 years who are unable to take oral medication or whom parenteral administration of IV Lacosamide is desirable. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
• To evaluate the safety of IV Lacosamide given as a rapid infusion. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  The safety of IV Lacosamide will be assessed in patients in whom parental administration of Lacosamide is warranted.

To evaluate the safety of IV Lacosamide in children with partial-onset epilepsy, ages 4-20 years old, inclusive, who are either unable to take oral medication or require intravenous administration of IV Lacosamide.

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 20 years, who are either unable to take oral medication, or whom parenteral administration of IV Lacosamide is desirable.

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

• Active Comparator: Group 1A
  Subjects 001, 002, 003, 004, 005
  Intervention: Drug: Lacosamide
• Active Comparator: Group 2A
  Subjects 006, 007, 008, 009, 010
  Intervention: Drug: Lacosamide
• Active Comparator: Group 3A
  Subjects 011, 012, 013, 014, 015
  Intervention: Drug: Lacosamide
• Active Comparator: Group 4A
  Subjects 016, 017, 018, 019, 020
  Intervention: Drug: Lacosamide
• Active Comparator: Group 1B
  Subjects 021, 022, 023, 024, 025
  Intervention: Drug: Lacosamide
• Active Comparator: Group 2B
  Subjects 026, 027, 028, 029, 030
  Intervention: Drug: Lacosamide
• Active Comparator: Group 3B
  Subjects 031, 032, 033, 034, 035
  Intervention: Drug: Lacosamide
• Active Comparator: Group 4B
  Subjects 036, 037, 038, 039, 040
  Intervention: Drug: Lacosamide

• 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.
• 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.

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 medial 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 20 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.