Epilepsy
Conditions
Keywords
epilepsy
Brief summary
The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.
Detailed description
The objective of this study is to evaluate the safety of IV Lacosamide in children ages 4 years to 35 years, inclusive who are unable to take oral medications or require parenteral administration of IV Lacosamide Occasionally, patients over the age of 20 are seen at LeBonheur Children's Hospital due to the complexity of their condition, or due to a long relationship with their physician. These are exceptions which are reviewed on a case by case basis and are approved by the hospital administrator for admissions and outpatient testing.
Interventions
DRUGIV Lacosamide
Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy.
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
Yes
Inclusion criteria
* Patient or LAR must sign informed consent * Diagnosis of partial onset currently uncontrolled * Patient must have received anti-epileptic drug therapy prior to initiation * Patient must have a medical condition in which parental administration is desireable * Male or female * Ages 4-35
Exclusion criteria
* Patient has participated in a study involving IV Lacosamide * Patient has had an episode of status epilepticus in the last 3 months * Drug history to lacosamide pregnant or lactating * If of child bearing age, must have pregnancy test * Patient has participated in an experimental drug study in last 30 days * Patients with significant active hepatic or renal disease. * Patients with known cardiac disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events (TEAEs), reported or observed. | 2 years | Bradycardia, hypotension, fatigue, nausea, somnolence. |
| Measure post-infusion lacosamide plasma concentrations | 2 years | Serum lacosamide level drawn from the arm opposite intravenous infusion |
| Measure changes in EKG, PR interval | 2 years | PR interval changes measured in seconds |
Countries
United States
Outcome results
None listed