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Efficacy and Safety of Rapid Titration Protocols of Lacosamide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03607851
Recruitment Status : Completed
First Posted : July 31, 2018
Last Update Posted : February 18, 2020
Sponsor:
Collaborators:
Dongsan Medical Center
Konkuk University
Information provided by (Responsible Party):
Sang Kun Lee, Seoul National University Hospital

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.

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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


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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607851


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Dongsan Medical Center
Konkuk University
Publications:
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Responsible Party: Sang Kun Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03607851    
Other Study ID Numbers: 0620181410
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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