Efficacy and Safety of Rapid Titration Protocols of Lacosamide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-03

Study Completion Date

2019-06-07

Brief Summary

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

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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.

Conditions

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Focal Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional titration group

Group Type ACTIVE_COMPARATOR

Lacosamide - conventional titration

Intervention Type 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

Rapid titration group 1

Group Type EXPERIMENTAL

Lacosamide - rapid titration 1

Intervention Type DRUG

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

Rapid titration group 2

Group Type EXPERIMENTAL

Lacosamide - rapid titration 2

Intervention Type 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

Interventions

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Lacosamide - 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

Intervention Type DRUG

Lacosamide - rapid titration 1

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

Intervention Type DRUG

Lacosamide - 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

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No