Back to resultsEfficacy and Safety of Rapid Titration Protocols of Lacosamide
Primary Purpose
Focal Epilepsy
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lacosamide - conventional titration
Lacosamide - rapid titration 1
Lacosamide - rapid titration 2
Sponsored by
About this trial
This is an interventional treatment trial for Focal Epilepsy
Eligibility 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Conventional titration group
Rapid titration group 1
Rapid titration group 2
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.
Secondary Outcome Measures
Reduction of seizure frequency
50% responder rate (percentage of patients achieving a 50% or greater reduction in seizure frequency)
lacosamide drug level in the blood
lacosamide drug level 1 week after the day of the daily dose of lacosamide reaches 400 mg/day
Full Information
NCT ID
NCT03607851
First Posted
July 24, 2018
Last Updated
February 16, 2020
Sponsor
Seoul National University Hospital
Collaborators
Dongsan Medical Center, Konkuk University
1. Study Identification
Unique Protocol Identification Number
NCT03607851
Brief Title
Efficacy and Safety of Rapid Titration Protocols of Lacosamide
Official Title
Efficacy and Safety of Rapid Titration Protocols of Lacosamide: An Exploratory Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 3, 2018 (Actual)
Primary Completion Date
June 7, 2019 (Actual)
Study Completion Date
June 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Dongsan Medical Center, Konkuk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional titration group
Arm Type
Active Comparator
Arm Title
Rapid titration group 1
Arm Type
Experimental
Arm Title
Rapid titration group 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lacosamide - conventional titration
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Lacosamide - rapid titration 1
Intervention Description
Administration of lacosamide by the following schedule, Initial: 100 mg PO BID Increase dose to 200 mg BID after one week
Intervention Type
Drug
Intervention Name(s)
Lacosamide - rapid titration 2
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.
Time Frame
6 (rapid titration group) or 8 weeks (conventional titration group)
Secondary Outcome Measure Information:
Title
Reduction of seizure frequency
Description
50% responder rate (percentage of patients achieving a 50% or greater reduction in seizure frequency)
Time Frame
Baseline, 6 weeks (rapid titration group) or 8 weeks (conventional titration group)
Title
lacosamide drug level in the blood
Description
lacosamide drug level 1 week after the day of the daily dose of lacosamide reaches 400 mg/day
Time Frame
2 weeks (rapid titration group) or 4 weeks (conventional titration group)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23859801
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(1):56-68. doi: 10.1111/nyas.12213.
Results Reference
background
PubMed Identifier
17635557
Citation
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. doi: 10.1111/j.1528-1167.2007.01188.x.
Results Reference
background
PubMed Identifier
19183227
Citation
Halasz P, Kalviainen 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.
Results Reference
background
PubMed Identifier
20132285
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.
Results Reference
background
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Efficacy and Safety of Rapid Titration Protocols of Lacosamide
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