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Efficacy and Safety of Rapid Titration Protocols of Lacosamide

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Seoul National University

Status and phase

Completed
Phase 4

Conditions

Focal Epilepsy

Treatments

Drug: Lacosamide - conventional titration
Drug: Lacosamide - rapid titration 2
Drug: Lacosamide - rapid titration 1

Study type

Interventional

Funder types

Other

Identifiers

NCT03607851
0620181410

Details and patient eligibility

About

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

Full 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.

Enrollment

75 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 3 patient groups

Conventional titration group
Active Comparator group
Treatment:
Drug: Lacosamide - conventional titration
Rapid titration group 1
Experimental group
Treatment:
Drug: Lacosamide - rapid titration 1
Rapid titration group 2
Experimental group
Treatment:
Drug: Lacosamide - rapid titration 2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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