Back to resultsIV Lacosamide: The Safety of Intravenous Lacosamide
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IV Lacosamide
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring epilepsy
Eligibility Criteria
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.
Sites / Locations
- Lebonheur Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
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.
IV Lacosamide to be administered (intravenously) over 15 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1mg/kg, 2,4 mg/kg
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events (TEAEs), reported or observed.
Bradycardia, hypotension, fatigue, nausea, somnolence.
Measure post-infusion lacosamide plasma concentrations
Serum lacosamide level drawn from the arm opposite intravenous infusion
Measure changes in EKG, PR interval
PR interval changes measured in seconds
Secondary Outcome Measures
Full Information
NCT ID
NCT01981447
First Posted
May 13, 2013
Last Updated
September 21, 2020
Sponsor
Le Bonheur Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01981447
Brief Title
IV Lacosamide: The Safety of Intravenous Lacosamide
Official Title
IV Lacosamide: The Safety of Intravenous Lacosamide
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Le Bonheur Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
IV Lacosamide to be administered (intravenously) over 15 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1mg/kg, 2,4 mg/kg
Intervention Type
Drug
Intervention Name(s)
IV Lacosamide
Other Intervention Name(s)
Vimpat
Intervention Description
Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy.
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events (TEAEs), reported or observed.
Description
Bradycardia, hypotension, fatigue, nausea, somnolence.
Time Frame
2 years
Title
Measure post-infusion lacosamide plasma concentrations
Description
Serum lacosamide level drawn from the arm opposite intravenous infusion
Time Frame
2 years
Title
Measure changes in EKG, PR interval
Description
PR interval changes measured in seconds
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James W Wheless, MD
Organizational Affiliation
Lebonheur Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lebonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
12. IPD Sharing Statement
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IV Lacosamide: The Safety of Intravenous Lacosamide
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