Viewing Study NCT03607851


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Study NCT ID: NCT03607851
Status: COMPLETED
Last Update Posted: 2020-02-18
First Post: 2018-07-24
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Efficacy and Safety of Rapid Titration Protocols of Lacosamide
Sponsor: Seoul National University Hospital
Organization:

Study Overview

Official Title: Efficacy and Safety of Rapid Titration Protocols of Lacosamide: An Exploratory Study
Status: COMPLETED
Status Verified Date: 2020-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Three different dose titration schedules are tested to find a way to reduce the titration period of lacosamide
Detailed Description: 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 Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: