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