IV Lacosamide: The Safety of Intravenous Lacosamide
- Registration Number
- NCT01981447
- Lead Sponsor
- Le Bonheur Children's Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group A IV Lacosamide IV Lacosamide administered (intravenously) over 30 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1 mg/ kg and 2.9 mg/kg over 30 minutes. Group B IV Lacosamide IV Lacosamide to be administered (intravenously) over 15 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1mg/kg, 2,4 mg/kg
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Lebonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States