Efficacy and Safety of Rapid Titration Protocols of Lacosamide

Phase 4

Completed

• Conditions: Focal Epilepsy
• Interventions: Drug: Lacosamide - rapid titration 1; Drug: Lacosamide - rapid titration 2; Drug: Lacosamide - conventional titration

• Registration Number: NCT03607851
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-31
• Study Start: 2018-08-03
• Primary Completion: 2019-06-07
• Study Completion: 2019-06-07
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-16
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid titration group 1	Lacosamide - rapid titration 1	-
Rapid titration group 2	Lacosamide - rapid titration 2	-
Conventional titration group	Lacosamide - conventional titration	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	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 Outcome Measures

Name	Time	Method
Reduction of seizure frequency	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)
lacosamide drug level in the blood	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of