Efficacy and Safety of Rapid Titration Protocols of Lacosamide

NCT03607851 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-02-18

No results posted yet for this study

Summary

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

Conditions

  • Focal Epilepsy

Interventions

DRUG

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

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

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

Sponsors & Collaborators

  • Dongsan Medical Center

    collaborator OTHER
  • Konkuk University

    collaborator OTHER
  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-03
Primary Completion
2019-06-07
Completion
2019-06-07

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03607851 on ClinicalTrials.gov