Epilepsy
Conditions
Keywords
partial, onset, epilepsy, pediatric, lacosamide, partial onset epilepsy, vimpat
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.
Interventions
DRUGLacosamide
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
Sponsors
Le Bonheur Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed