Effectiveness and adverse effect of intravenous lacosamide in nonconvulsive status epilepticus and acute repetitive seizures in children
Study ID: TCTR20180508004
Current status: Active, not recruiting
Last Updated: May 08, 2018
Tracking Information
Date of Registration in Primary Registry: May 07, 2018
Date of First Enrollment: January 04, 2016 (Actual)
Target Sample Size: 11
Last Updated Date: May 08, 2018
Primary Outcome(s):
  • Outcome name: seizure outcome
       Metric/method of measurement: Comparison between frequency of seizure baseline 1 month and % of seizure reduction after i.v. LCM
       Time point: during i.v. LCM treatment at 24 hours and 1 week
       Safety Issue?: Yes


  • Key Secondary Outcomes:
  • Outcome name: adverse effect of Lacosamide
       Metric/method of measurement: observation
       Time point: during i.v. LCM treatment at 24 hours and 1 week
       Safety Issue?: Yes


  • Descriptive Information
    Public Title: Effectiveness and adverse effect of intravenous lacosamide in nonconvulsive status epilepticus and acute repetitive seizures in children
    Scientific Title: Effectiveness and adverse effect of intravenous lacosamide in nonconvulsive status epilepticus and acute repetitive seizures in children
    Brief Summary:
    Detailed Description:
    Study Design: Allocation: Non-randomized
    Control: Uncontrolled
    Study Endpoint Classification: Safety/Efficacy Study
    Intervention Model: Single Group
    Number of Arms: 1
    Masking: Open Label (Masked Roles: )
    Primary Purpose: Treatment
    Study Phase: N/A
    Health Condition(s) or Problem(s) Studied: Nonconvulsive status epilepticus or acute repetitive seizures
    Study Arms:
  • Arm: 1
  • Intervention Name: IV Lacosamide
    Type: Experimental
    Classification: Drug
    Descriptions: A prospective interventional study was conducted in children under 18 years of age with NCSE or ARS who either had contraindication to, or were refractory to first-line AEDs, and received intravenous lacosamide.
    Recruitment Information
    Recruitment Status: Active, not recruiting
    Estimated Enrollment: 11
    Study Start Date (First enrollment): January 04, 2016
    Primary Completion Date: January 12, 2017
    Inclusion Criteria:
    Inclusion Criteria
    Gender: Both
    Age Limit: Minimum 0 N/A (No limit) : Maximum 18 Years
    1 patients with status epilepticus and or acute repetitive seizures aged less than 18 years
    2 patients who had uncontrollable seizures after first line antiepileptic drug therapies
    3 patients with a contraindication to first line antiepileptic drugs allergy to drugs comorbidity drug interaction risk of side effects
    Exclusion Criteria
    1 Lacosamide use within 1 month
    2 Allergic to lacosamide
    3 Pregnancy patients
    4 Underlying disease of cardiac AV block

    Accept Healthy Volunteers: No
    Countries of Recruitment Thailand
    Contact for Public Queries:
    Contact for Public Query's Name: Piradee Suwanpakdee
    Degree: MD
    Phone: +664383634
    Email: piradee@pedpmk.org
    Postal Address: 315 Ratchawithi Rd.
    State/Province: Bangkok        Postal Code: 10400
    Country: Thailand
    Contact for Public Query's Name: Piradee Suwanpakdee
    Degree: MD
    Phone: +664383634
    Email: piradee@pedpmk.org
    Postal Address: Ratchathewi
    State/Province: Bangkok        Postal Code: 10400
    Country: Thailand
    Administrative Information
    Primary Registry Site: Thai Clinical Trials Registry
    Trial Identification Number: TCTR20180508004
    Secondary Identifying Numbers: R052h/59
    Source(s) of Monetary or Material Supports: Phramongkutklao hospital
    Study Primary Sponsor: Phramongkutklao hospital
    Study Secondary Sponsor: 1.) None
    Contact for Scientific Queries:
    Contact for Scientific Query's Name: Piradee Suwanpakdee
    Degree: MD
    Phone: +664383634
    Email: piradee@pedpmk.org
    Postal Address: 315 Ratchawithi Rd.
    State/Province: Bangkok        Postal Code: 10400
    Country: Thailand
    Track changes

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