Efficacy and Safety of Rapid Titration Protocols of Lacosamide

Focal Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607851
• Other study ID #: 0620181410
• Status: Completed
• Phase: Phase 4
• Start date: August 3, 2018
• Est. completion date: June 7, 2019

Study information

• Verified date: February 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Focal Epilepsy

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Dongsan Medical Center, Konkuk University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Ben-Menachem E, Biton V, Jatuzis D, Abou-Khalil B, Doty P, Rudd GD. Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures. Epilepsia. 2007 Jul;48(7):1308-17. — View Citation

Chung S, Sperling MR, Biton V, Krauss G, Hebert D, Rudd GD, Doty P; SP754 Study Group. Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial. Epilepsia. 2010 Jun;51(6):958-67. doi: 10.1111/j.1528-1167.2009.02496.x. Epub 2010 Jan 27. — View Citation

Doty P, Hebert D, Mathy FX, Byrnes W, Zackheim J, Simontacchi K. Development of lacosamide for the treatment of partial-onset seizures. Ann N Y Acad Sci. 2013 Jul;1291:56-68. doi: 10.1111/nyas.12213. Review. — View Citation

Halász P, Kälviäinen R, Mazurkiewicz-Beldzinska M, Rosenow F, Doty P, Hebert D, Sullivan T; SP755 Study Group. Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results from a randomized controlled trial. Epilepsia. 2009 Mar;50(3):443-53. doi: 10.1111/j.1528-1167.2008.01951.x. Epub 2009 Jan 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.	6 (rapid titration group) or 8 weeks (conventional titration group)
Secondary	Reduction of seizure frequency	50% responder rate (percentage of patients achieving a 50% or greater reduction in seizure frequency)	Baseline, 6 weeks (rapid titration group) or 8 weeks (conventional titration group)
Secondary	lacosamide drug level in the blood	lacosamide drug level 1 week after the day of the daily dose of lacosamide reaches 400 mg/day	2 weeks (rapid titration group) or 4 weeks (conventional titration group)