Efficacy and Safety of Rapid Titration Protocols of Lacosamide

Study Overview
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Brief Summary
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Three different dose titration schedules are tested to find a way to reduce the titration period of lacosamide

Detailed Description
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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.

Official Title
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Efficacy and Safety of Rapid Titration Protocols of Lacosamide: An Exploratory Study

Conditions
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Focal Epilepsy

Intervention / Treatment
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* Drug: Lacosamide - conventional titration
* Drug: Lacosamide - rapid titration 1
* Drug: Lacosamide - rapid titration 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional titration group<br> | Drug: Lacosamide - conventional titration<br>* 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<br>|
| Experimental: Rapid titration group 1<br> | Drug: Lacosamide - rapid titration 1<br>* Administration of lacosamide by the following schedule, Initial: 100 mg PO BID Increase dose to 200 mg BID after one week<br>|
| Experimental: Rapid titration group 2<br> | Drug: Lacosamide - rapid titration 2<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |