Clinical trial NCT03607851: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Focal Epilepsy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Dongsan Medical Center
name: Konkuk University
First posted: 2018-07-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 6 (rapid titration group) or 8 weeks (conventional titration group)
Secondary outcomes:
measure: Reduction of seizure frequency
timeFrame: Baseline, 6 weeks (rapid titration group) or 8 weeks (conventional titration group)
measure: lacosamide drug level in the blood
timeFrame: 2 weeks (rapid titration group) or 4 weeks (conventional titration group)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
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.
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.
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.
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.