Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management

• Status: Terminated
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborator: UCB Pharma GmbH
• Treatments: Lacosamide; Phenytoin

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