Lacosamide IV and EEG/EKG (LIVE) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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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

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Focal Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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100 mg IV

100 mg IV lacosamide infused over 30 minutes

Group Type OTHER

Lacosamide

Intervention Type DRUG

200 mg IV

200 mg IV lacosamide infused over 30 minutes

Group Type OTHER

Lacosamide

Intervention Type DRUG

400 mg IV

400 mg IV lacosamide infused over 30 minutes

Group Type OTHER

Lacosamide

Intervention Type DRUG

Interventions

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Lacosamide

Intervention Type DRUG

Other Intervention Names

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Vimpat

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No