The Safety of Intravenous Lacosamide
Study Details
Study Description
Brief Summary
To evaluate the safety of IV Lacosamide in children with partial-onset epilepsy, ages 4-35 years old, inclusive, who are either unable to take oral medication or require intravenous administration of IV Lacosamide.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Detailed Description
Lacosamide tablets and intravenous formulations were both approved in the United States in the fall of 2008. Lacosamide is indicated for use as adjunctive therapy in the treatment of partial onset seizure disorder in patients' age seventeen years and older. A parenteral dosage form of Lacosamide is desirable for patients who are temporarily unable to take medication orally. The objective of this study is to evaluate the safety of IV Lacosamide in children with epilepsy, ages 4 to 35 years, who are either unable to take oral medication, or whom parenteral administration of IV Lacosamide is desirable.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Group 1A Lacosamide, IV, 50 mg, once, 30 minutes |
Drug: Lacosamide
0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes.
0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes
Other Names:
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Active Comparator: Group 2A Lacosamide, IV, 100 mg, once, 30 min |
Drug: Lacosamide
0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes.
0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes
Other Names:
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Active Comparator: Group 3A Lacosamide, IV, 150 mg, once, 30 min |
Drug: Lacosamide
0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes.
0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes
Other Names:
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Active Comparator: Group 4A Lacosamide, IV, 200 mg, once, 30 min |
Drug: Lacosamide
0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes.
0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes
Other Names:
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Active Comparator: Group 1B Lacosamide, IV, 50 mg, once, 15 min |
Drug: Lacosamide
0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes.
0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes
Other Names:
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Active Comparator: Group 2B Lacosamide, IV, 100 mg, once, 15 min |
Drug: Lacosamide
0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes.
0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes
Other Names:
|
Active Comparator: Group 3B Lacosamide, IV, 150 mg, once, 15 min |
Drug: Lacosamide
0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes.
0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes
Other Names:
|
Active Comparator: Group 4B Lacosamide, IV, 200 mg, once, 15 min |
Drug: Lacosamide
0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes.
0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes
Other Names:
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Outcome Measures
Primary Outcome Measures
- To evaluate the safety of IV Lacosamide given as a rapid infusion. [one year]
The safety of IV Lacosamide will be assessed in patients in whom parental administration of Lacosamide is warranted.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients must have a diagnosis of epilepsy and have received anti-epileptic drug therapy prior to initiation of IV Lacosamide
-
Patients must have a medical condition in which the parenteral administration of Lacosamide is desirable.
-
Patients may be male or female.
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Patients must be 4 years of age or older, and less than age 35 years.
-
Patient or his / her legally authorized representative must sign an informed consent form prior to any study specific procedures.
Exclusion Criteria:
-
Patients will be excluded from entry into the study if any of the following are true:
-
Patient has previously participated in any other intravenous Lacosamide study.
-
Patient has status epilepticus within the last 3 months.
-
Patient has a history of drug allergy to Lacosamide.
-
Patient is pregnant.
-
Patient has taken experimental drug within last 30 days.
-
Patient with significant hepatic or renal disease.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | LeBonheur Children's Medical Center | Memphis | Tennessee | United States | 38103 |
Sponsors and Collaborators
- Le Bonheur Children's Hospital
Investigators
- Principal Investigator: James W Wheless, MD, LeBonheur Children's Medical Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 00570-FB
- NCT00720863