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Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management

Information source: Lawson Health Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Seizures

Intervention: lacosamide (Drug); Phenytoin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Lawson Health Research Institute

Official(s) and/or principal investigator(s):
Jorge Burneo, MD, Principal Investigator, Affiliation: Lawson Health Research Institute

Overall contact:
Jorge Burneo, MD, Phone: (519) 663-3464, Email: jburneo2@uwo.ca


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.

Clinical Details

Official title: Prospective, Randomized, Single-blinded Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Incidence of Clinical Adverse Events

Secondary outcome: Efficacy


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Jorge Burneo, MD, Phone: (519) 663-3464, Email: jburneo2@uwo.ca

University Hospital, London, Ontario N6A 5A5, Canada; Recruiting
Jorge Burneo, MD, Phone: (519) 663-3464, Email: jburneo2@uwo.ca
Jorge Burneo, MD, Principal Investigator
Additional Information

Starting date: August 2014
Last updated: April 7, 2015

Page last updated: August 23, 2015

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