Focal Epilepsy
Conditions
Keywords
IV lacosamide, focal epilepsy, EEG, EKG
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.
Interventions
DRUGLacosamide
Sponsors
UCB Pharma GmbH
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the number of interictal spikes | One hour before and after drug |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Other
| Measure | Time frame |
|---|---|
| Adverse events | Up to 4 hours after start of infusion |
Countries
Canada
Outcome results
None listed