Efficacy and Safety of Rapid Titration Protocols of Lacosamide

• ClinicalTrials.gov Identifier: NCT03607851
• Recruitment Status: Completed
• First Posted: July 31, 2018
• Last Update Posted: February 18, 2020
• Sponsor: Seoul National University Hospital
• Collaborators: Dongsan Medical Center; Konkuk University
• Information provided by (Responsible Party): Sang Kun Lee, Seoul National University Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Focal Epilepsy	Drug: Lacosamide - conventional titration; Drug: Lacosamide - rapid titration 1; Drug: Lacosamide - rapid titration 2	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Rapid Titration Protocols of Lacosamide: An Exploratory Study
• Actual Study Start Date: August 3, 2018
• Actual Primary Completion Date: June 7, 2019
• Actual Study Completion Date: June 7, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Conventional titration group	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
Experimental: Rapid titration group 1	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
Experimental: Rapid titration group 2	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

Outcome Measures

Primary Outcome Measures :

1. Incidence of adverse events [ Time Frame: 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 :

1. Reduction of seizure frequency [ Time Frame: 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)
2. lacosamide drug level in the blood [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

Seoul National University Hospital

Seoul, Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Dongsan Medical Center

Konkuk University

More Information

Publications:

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.

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.

Halász P, Kälviäinen R, Mazurkiewicz-Beldzińska 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.

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.

• Responsible Party: Sang Kun Lee, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03607851
• Other Study ID Numbers: 0620181410
• First Posted: July 31, 2018
• Last Update Posted: February 18, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Lacosamide; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action