Overview

Lacosamide IV and EEG/EKG (LIVE) Study

Status:
Terminated

Trial end date:
2016-08-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Lawson Health Research Institute

Collaborator:

UCB Pharma GmbH

Treatments:

Lacosamide

Criteria

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.