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| Name | Class |
|---|---|
| Dongsan Medical Center | OTHER |
| Konkuk University | OTHER |
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Three different dose titration schedules are tested to find a way to reduce the titration period of lacosamide
The investigators intend to find a way to reduce the titration period of lacosamide. Dosage of lacosamide is increased from 100-200 mg/d to 400 mg/d by three different titration schedule. Safety of lacosamide administration is primary endpoint. 50% responder rate (seizure reduction) and blood level of lacosamide are investigated for secondary endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional titration group | Active Comparator |
| |
| Rapid titration group 1 | Experimental |
| |
| Rapid titration group 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide - conventional titration | Drug | Administration of lacosamide by the following schedule, Initial: 50 mg PO BID Increase dose at weekly intervals by 50 mg PO BID; up to 200 mg BID |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4. | 6 (rapid titration group) or 8 weeks (conventional titration group) |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of seizure frequency | 50% responder rate (percentage of patients achieving a 50% or greater reduction in seizure frequency) | Baseline, 6 weeks (rapid titration group) or 8 weeks (conventional titration group) |
| lacosamide drug level in the blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23859801 | Background | Doty P, Hebert D, Mathy FX, Byrnes W, Zackheim J, Simontacchi K. Development of lacosamide for the treatment of partial-onset seizures. Ann N Y Acad Sci. 2013 Jul;1291(1):56-68. doi: 10.1111/nyas.12213. | |
| 17635557 | Background | Ben-Menachem E, Biton V, Jatuzis D, Abou-Khalil B, Doty P, Rudd GD. Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures. Epilepsia. 2007 Jul;48(7):1308-17. doi: 10.1111/j.1528-1167.2007.01188.x. |
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| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Lacosamide - rapid titration 1 | Drug | Administration of lacosamide by the following schedule, Initial: 100 mg PO BID Increase dose to 200 mg BID after one week |
|
| Lacosamide - rapid titration 2 | Drug | Administration of lacosamide by the following schedule, Initial: 50 mg PO BID Increase dose every two days by 50 mg PO BID; up to 200 mg BID |
|
lacosamide drug level 1 week after the day of the daily dose of lacosamide reaches 400 mg/day |
| 2 weeks (rapid titration group) or 4 weeks (conventional titration group) |
| 19183227 | Background | Halasz P, Kalviainen R, Mazurkiewicz-Beldzinska M, Rosenow F, Doty P, Hebert D, Sullivan T; SP755 Study Group. Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results from a randomized controlled trial. Epilepsia. 2009 Mar;50(3):443-53. doi: 10.1111/j.1528-1167.2008.01951.x. Epub 2009 Jan 17. |
| 20132285 | Background | Chung S, Sperling MR, Biton V, Krauss G, Hebert D, Rudd GD, Doty P; SP754 Study Group. Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial. Epilepsia. 2010 Jun;51(6):958-67. doi: 10.1111/j.1528-1167.2009.02496.x. Epub 2010 Jan 27. |