NCT01724918

Lacosamide IV and EEG/EKG (LIVE) Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of different intravenous doses (IV) of a new anti-epileptic drug (AED) called lacosamide on continuous EEG (electroencephalogram) rhythms (or brain rhythms) in subjects with focal seizures and the tolerability of those doses by patients. In addition, this study will assess the effect of IV lacosamide on EKG (electrocardiogram), a test which checks for problems with the electrical activity of the heart.

Detailed description

The impact of antiepileptic drugs on the EEG can vary from marked to none. A small number of AEDs also affect the EKG. Lacosamide is a new AED that selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing. Information is lacking about the effect of lacosamide on brain and heart rhythms.

Conditions

• Focal Epilepsy

Interventions

Type	Name	Description
DRUG	Lacosamide

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2012-11-12
• Last updated: 2016-09-26

Locations

4 sites across 1 country: Canada