IV Lacosamide: The Safety of Intravenous Lacosamide
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
November 11, 2013
CompletedSeptember 22, 2020
September 1, 2020
2.3 years
May 13, 2013
September 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of participants with treatment-related adverse events (TEAEs), reported or observed.
Bradycardia, hypotension, fatigue, nausea, somnolence.
2 years
Measure post-infusion lacosamide plasma concentrations
Serum lacosamide level drawn from the arm opposite intravenous infusion
2 years
Measure changes in EKG, PR interval
PR interval changes measured in seconds
2 years
Study Arms (2)
Group A
ACTIVE COMPARATORIV 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
ACTIVE COMPARATORIV Lacosamide to be administered (intravenously) over 15 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1mg/kg, 2,4 mg/kg
Interventions
Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lebonheur Children's Hospital
Memphis, Tennessee, 38103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James W Wheless, MD
Lebonheur Children's Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigaor, Neurolgy Division Chief
Study Record Dates
First Submitted
May 13, 2013
First Posted
November 11, 2013
Study Start
April 1, 2010
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
September 22, 2020
Record last verified: 2020-09