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Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT02409433
Collaborator
UCB Pharma GmbH (Industry)
3
Enrollment
1
Location
2
Arms
15
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Investigator plans to perform a prospective, randomized, single blinded, study that will compare patients treated with IV lacosamide to those treated with Phenytoin in the Intensive Care Unit (ICU) setting. The investigator will also evaluate the rate of clinically evident and sub-clinical seizures, and to compare long-term outcomes between patients treated with lacosamide and those treated with Phenytoin.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Prospective, Randomized, Single-blinded Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: lacosamide

The lacosamide group will receive a loading dose of 400 mg IV, and on maintenance dose of up to 400 mg every 12 hours.

Drug: lacosamide
Comparison of patients treated with IV lacosamide to those treated with phenytoin in the intensive care unit setting. The lacosamide group will receive a loading dose of 400 mg IV, and on maintenance dose of up to 400 mg every 12 hours.
Other Names:
  • Vimpat

    		•
    Active Comparator: phenytoin

    the phenytoin group will receive a loading dose of 20 mg/K IV, maximum of 2000 mg, given over 60 min. and will be started on a maintenance dose of 5 mg/K/day. Levels will be checked accordingly.

    Drug: Phenytoin
    the phenytoin group will receive a loading dose of 20 mg/K IV, maximum of 2000 mg, given over 60 min. and will be started on a maintenance dose of 5 mg/K/day.
    Other Names:
  • Dilantin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Clinical Adverse Events [6 months]

      Safety: the primary outcome measure will be the incidence of clinical adverse events. Patients will be evaluated daily during the hospital stay for seizures, fever, neurological changes, cardiovascular, hematologic and dermatologic abnormalities, liver failure, renal failure, and death. Each adverse event will be classified by the principal investigator as attributable or possibly attributable to the study drug versus other events. Serious adverse events for these to study will be defined as those that result in death, prolonged hospitalization, life threatening events, persistent or significant disability, or an important medical event that may not be immediately life threatening or result in death but based upon appropriate medical judgment may jeopardize the participant, or may require medical or surgical intervention to prevent one of the other outcomes listed.

    Secondary Outcome Measures

    1. Efficacy [6 months]

      Efficacy: the secondary endpoints will be seizure frequency and long-term outcomes (measure by disability scales). All patients will be monitored on continuous EEG for 72 hours or until a week and following commands. Since over 50% of initial seizure activity in these patients are usually subclinical as reported in the finished studies, and about 90% of the seizures happen within the first two days of admission to the ICU, the investigator would stop EEG recordings once patient awake, or by 72 hours after admission if there were no seizures.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Traumatic Brain Injury (TBI) or Subarachnoid hemorrhage (SAH)

    • Admitted to the hospital less than 48 hours prior to randomization

    • Glasgow Coma Scale (GCS) score 3-8 (inclusive), or GCS motor score of five or less and abnormal CT scan showing intracranial pathology

    • Hemodynamically stable

    • Older than 18 years of age

    Exclusion Criteria:

    • No IV access

    • Spinal cord injury

    • History of or CT confirmation of previous brain injury, including brain tumor, stroke, or a spontaneous intracerebral hemorrhage

    • Hemodynamically unstable

    • Suspected anoxia

    • Liver failure

    • Younger than 18 years of age

    • Pregnant

    • Allergy to phenytoin or lacosamide

    • Inability to obtain consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital London Ontario Canada N6A 5A5

    Sponsors and Collaborators

    • Lawson Health Research Institute
    • UCB Pharma GmbH

    Investigators

    • Principal Investigator: Jorge Burneo, MD, Lawson Health Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jorge Burneo, Principal Investigator, Lawson Health Research Institute
    ClinicalTrials.gov Identifier:
    NCT02409433
    Other Study ID Numbers:
    • 100739
    First Posted:
    Apr 6, 2015
    Last Update Posted:
    Jan 7, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by Jorge Burneo, Principal Investigator, Lawson Health Research Institute
    lacosamide
    phenytoin
    Additional relevant MeSH terms:
    Seizures
    Lacosamide
    Phenytoin

    Study Results

    No Results Posted as of Jan 7, 2016