Lacosamide IV and EEG/EKG (LIVE) Study

Phase 2

Terminated

• Conditions: Focal Epilepsy
• Interventions: Drug: Lacosamide

• Registration Number: NCT01724918
• Lead Sponsor: Lawson Health Research Institute

Brief 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.

Study Timeline

• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-11-07
• Study First Posted: 2012-11-12
• Study Start: 2013-05
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-23
• Last Update Posted: 2016-09-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
2. Adult patients 18-65 years
3. Diagnosis of focal epilepsy
4. Continuous EEG and video monitoring
5. Continuous EKG
6. Active EEG showing frequent spikes, electrographic or clinical seizures

Exclusion Criteria

1. Subject has no IV access.
2. Subject is hemodynamically unstable.
3. Previous use of Lacosamide
4. Primary generalized epilepsy
5. Non-epileptic seizures
6. No significant cardiac, renal or hepatic disease
7. No cardiac arrhythmias including heart block
8. Subject is a pregnant or lactating woman.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
200 mg IV	Lacosamide	200 mg IV lacosamide infused over 30 minutes
100 mg IV	Lacosamide	100 mg IV lacosamide infused over 30 minutes
400 mg IV	Lacosamide	400 mg IV lacosamide infused over 30 minutes

Primary Outcome Measures

Name	Time	Method
Change in the number of interictal spikes	One hour before and after drug

Secondary Outcome Measures

Name	Time	Method
Change in frequency and quantity of background EEG rhythms	One hour before and after drug
Change in EKG (QT, PR interval and heart rhythm)	One hour before and after drug

Trial Locations

Locations (4)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Foothills Medical Center; 🇨🇦 Calgary, Alberta, Canada

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada