Efficacy and Safety of Rapid Titration Protocols of Lacosamide

Seoul National University Hospital75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Focal Epilepsy

Interventions

Lacosamide - conventional titrationDRUG

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

Lacosamide - rapid titration 1DRUG

Administration of lacosamide by the following schedule, Initial: 100 mg PO BID Increase dose to 200 mg BID after one week

Lacosamide - rapid titration 2DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Incidence of adverse events

Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.

Time frame: 6 (rapid titration group) or 8 weeks (conventional titration group)

Secondary Outcomes

Reduction of seizure frequency

50% responder rate (percentage of patients achieving a 50% or greater reduction in seizure frequency)

Time frame: 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

Time frame: 2 weeks (rapid titration group) or 4 weeks (conventional titration group)

Data from ClinicalTrials.gov

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