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Completed

NCT Number: NCT03607851

Efficacy and Safety of Rapid Titration Protocols of Lacosamide

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

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Key information

Conditions

Focal Epilepsy Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Incidence of adverse events

    Time frame: 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 outcomes

  1. Reduction of seizure frequency

    Time frame: 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)

  2. lacosamide drug level in the blood

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Dongsan Medical Center
  • Konkuk University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 31, 2018
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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