Lebonheur Children's Hospital
Memphis, Tennessee, 38103, United States
NCT Number: NCT01981447
The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.
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Notify Me4 year–35 year
All sexes
Interventional
Phase 3
Memphis, Tennessee, 38103, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy.
Other names: Vimpat
Time frame: 2 years
Bradycardia, hypotension, fatigue, nausea, somnolence.
Time frame: 2 years
Serum lacosamide level drawn from the arm opposite intravenous infusion
Time frame: 2 years
PR interval changes measured in seconds
Le Bonheur Children's Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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