The Safety of Intravenous Lacosamide

Le Bonheur Children's Hospital

Status and phase: Completed; Phase 4

Conditions: Epilepsy

Treatments: Drug: Lacosamide

Study type: Interventional

Funder types: Other

Identifiers

NCT00832884

00570-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 4 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 8 patient groups

Group 1A

Active Comparator group

Description:

Lacosamide, IV, 50 mg, once, 30 minutes

Treatment:

Drug: Lacosamide

Group 2A

Active Comparator group

Description:

Lacosamide, IV, 100 mg, once, 30 min

Treatment:

Drug: Lacosamide

Group 3A

Active Comparator group

Description:

Lacosamide, IV, 150 mg, once, 30 min

Treatment:

Drug: Lacosamide

Group 4A

Active Comparator group

Description:

Lacosamide, IV, 200 mg, once, 30 min

Treatment:

Drug: Lacosamide

Group 1B

Active Comparator group

Description:

Lacosamide, IV, 50 mg, once, 15 min

Treatment:

Drug: Lacosamide

Group 2B

Active Comparator group

Description:

Lacosamide, IV, 100 mg, once, 15 min

Treatment:

Drug: Lacosamide

Group 3B

Active Comparator group

Description:

Lacosamide, IV, 150 mg, once, 15 min

Treatment:

Drug: Lacosamide

Group 4B

Active Comparator group

Description:

Lacosamide, IV, 200 mg, once, 15 min

Treatment:

Drug: Lacosamide