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The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | 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 | Active Comparator | IV Lacosamide to be administered (intravenously) over 15 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1mg/kg, 2,4 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Lacosamide | Drug | Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James W Wheless, MD | Lebonheur Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lebonheur Children's Hospital | Memphis | Tennessee | 38103 | United States |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Acids, Acyclic |
| D002264 | Carboxylic Acids |