NCT03607851

Efficacy and Safety of Rapid Titration Protocols of Lacosamide

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Focal Epilepsy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-08-03
• Primary completion: 2019-06-07
• Completion: 2019-06-07
• First posted: 2018-07-31
• Last updated: 2020-02-18

Locations

1 site across 1 country: South Korea