NCT02409433

Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Seizures

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-04-06
• Last updated: 2016-01-07

Locations

1 site across 1 country: Canada