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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1A | Active Comparator | Lacosamide, IV, 50 mg, once, 30 minutes |
|
| Group 2A | Active Comparator | Lacosamide, IV, 100 mg, once, 30 min |
|
| Group 3A | Active Comparator | Lacosamide, IV, 150 mg, once, 30 min |
|
| Group 4A | Active Comparator | Lacosamide, IV, 200 mg, once, 30 min |
|
| Group 1B | Active Comparator | Lacosamide, IV, 50 mg, once, 15 min |
|
| Group 2B | Active Comparator | Lacosamide, IV, 100 mg, once, 15 min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of IV Lacosamide given as a rapid infusion. | The safety of IV Lacosamide will be assessed in patients in whom parental administration of Lacosamide is warranted. | one year |
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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 Medical Center | Memphis | Tennessee | 38103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17888078 | Result | Biton V, Rosenfeld WE, Whitesides J, Fountain NB, Vaiciene N, Rudd GD. Intravenous lacosamide as replacement for oral lacosamide in patients with partial-onset seizures. Epilepsia. 2008 Mar;49(3):418-24. doi: 10.1111/j.1528-1167.2007.01317.x. Epub 2007 Sep 19. | |
| 11137386 | Result | Bialer M, Johannessen SI, Kupferberg HJ, Levy RH, Loiseau P, Perucca E. Progress report on new antiepileptic drugs: a summary of the Fifth Eilat Conference (EILAT V). Epilepsy Res. 2001 Jan;43(1):11-58. doi: 10.1016/s0920-1211(00)00171-6. |
| Label | URL |
|---|---|
| Study site website | View source |
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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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| Group 3B |
| Active Comparator |
Lacosamide, IV, 150 mg, once, 15 min |
|
| Group 4B | Active Comparator | Lacosamide, IV, 200 mg, once, 15 min |
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| Acids, Acyclic |
| D002264 | Carboxylic Acids |