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Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management

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ClinicalTrials.gov Identifier: NCT02409433
Recruitment Status : Terminated (due to slow recruitment and budgetary restraints study was prematurely terminated)
First Posted : April 6, 2015
Last Update Posted : January 7, 2016
Sponsor:
Collaborator:
UCB Pharma GmbH
Information provided by (Responsible Party):
Jorge Burneo, Lawson Health Research Institute

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
Seizures Drug: lacosamide Drug: Phenytoin Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : August 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

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 Name: 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 Name: Dilantin




Primary Outcome Measures :
  1. Incidence of Clinical Adverse Events [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02409433


Locations
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Canada, Ontario
University Hospital
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
UCB Pharma GmbH
Investigators
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Principal Investigator: Jorge Burneo, MD Lawson Health Research Institute

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Responsible Party: Jorge Burneo, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02409433     History of Changes
Other Study ID Numbers: 100739
First Posted: April 6, 2015    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016

Keywords provided by Jorge Burneo, Lawson Health Research Institute:
lacosamide
phenytoin

Additional relevant MeSH terms:
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Phenytoin
Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers