Efficacy and Safety of Rapid Titration Protocols of Lacosamide: An Exploratory Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Conventional titration group
Intervention: Lacosamide - conventional titration (Drug)
Rapid titration group 1
Intervention: Lacosamide - rapid titration 1 (Drug)
Rapid titration group 2
Intervention: Lacosamide - rapid titration 2 (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Reduction of seizure frequency(Baseline, 6 weeks (rapid titration group) or 8 weeks (conventional titration group))
- lacosamide drug level in the blood(2 weeks (rapid titration group) or 4 weeks (conventional titration group))
Investigators
Sang Kun Lee
Professor
Seoul National University Hospital