Focal Epilepsy
Conditions
Brief summary
Three different dose titration schedules are tested to find a way to reduce the titration period of lacosamide
Detailed description
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.
Interventions
DRUGLacosamide - conventional titration
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
DRUGLacosamide - rapid titration 1
Administration of lacosamide by the following schedule, Initial: 100 mg PO BID Increase dose to 200 mg BID after one week
DRUGLacosamide - rapid titration 2
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
Sponsors
Dongsan Medical Center
Konkuk University
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-85 years old * Patients diagnosed with focal epilepsy * Patients subjected to the addition of lacosamide to treat focal onset seizures according to physician's judgement * Subjects provided informed consent
Exclusion criteria
* Subjects who changed other antiepileptic drugs at the beginning of lacosamide treatment * Subjects with unstable physical, mental or other disease condition that can impede with accurate evaluation or treatment * Subjects with terminal illness or general medical condition that can impede with the participation of the clinical trial * Subjects who do not agree with prior consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 6 (rapid titration group) or 8 weeks (conventional titration group) | Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of seizure frequency | Baseline, 6 weeks (rapid titration group) or 8 weeks (conventional titration group) | 50% responder rate (percentage of patients achieving a 50% or greater reduction in seizure frequency) |
| lacosamide drug level in the blood | 2 weeks (rapid titration group) or 4 weeks (conventional titration group) | lacosamide drug level 1 week after the day of the daily dose of lacosamide reaches 400 mg/day |
Countries
South Korea
Outcome results
None listed