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Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management

Primary Purpose

Seizures

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
lacosamide
Phenytoin
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizures focused on measuring lacosamide, phenytoin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

lacosamide

phenytoin

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Incidence of Clinical Adverse Events
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

Efficacy
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.

Full Information

First Posted
April 1, 2015
Last Updated
January 5, 2016
Sponsor
Lawson Health Research Institute
Collaborators
UCB Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02409433
Brief Title
Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management
Official Title
Prospective, Randomized, Single-blinded Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
due to slow recruitment and budgetary restraints study was prematurely terminated
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
UCB Pharma GmbH

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures
Keywords
lacosamide, phenytoin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lacosamide
Arm Type
Experimental
Arm Description
The lacosamide group will receive a loading dose of 400 mg IV, and on maintenance dose of up to 400 mg every 12 hours.
Arm Title
phenytoin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
lacosamide
Other Intervention Name(s)
Vimpat
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Phenytoin
Other Intervention Name(s)
Dilantin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Clinical Adverse Events
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Efficacy
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Burneo, MD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

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Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management

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