Lacosamide IV and EEG/EKG (LIVE) Study

Lawson Health Research Institute

Status and phase: Terminated; Phase 2

Conditions: Focal Epilepsy

Treatments: Drug: Lacosamide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01724918

LIVE 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 3 patient groups

100 mg IV

Other group

Description:

100 mg IV lacosamide infused over 30 minutes

Treatment:

Drug: Lacosamide

200 mg IV

Other group

Description:

200 mg IV lacosamide infused over 30 minutes

Treatment:

Drug: Lacosamide

400 mg IV

Other group

Description:

400 mg IV lacosamide infused over 30 minutes

Treatment:

Drug: Lacosamide