Clinical trial NCT01724918: Lacosamide IV and EEG/EKG (LIVE) Study
Official title: Lacosamide IV and EEG/EKG (LIVE) Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Focal Epilepsy
Keywords: IV lacosamide
focal epilepsy
EEG
EKG
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: UCB Pharma GmbH
First posted: 2012-11-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in the number of interictal spikes
timeFrame: One hour before and after drug
Secondary outcomes:
measure: Change in frequency and quantity of background EEG rhythms
timeFrame: One hour before and after drug
measure: Change in EKG (QT, PR interval and heart rhythm)
timeFrame: One hour before and after drug
Other outcomes:
measure: Adverse events
timeFrame: Up to 4 hours after start of infusion
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: London Health Sciences Centre, University Campus
name: Richard McLachlan, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: