Study Stopped
Time limitation for recruitment exceeded. 72 of 90 estimated sample recruited.
Lacosamide IV and EEG/EKG (LIVE) Study
LIVE
1 other identifier
interventional
72
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2013
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2012
CompletedFirst Posted
Study publicly available on registry
November 12, 2012
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedSeptember 26, 2016
September 1, 2016
3.3 years
October 31, 2012
September 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the number of interictal spikes
One hour before and after drug
Secondary Outcomes (2)
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 Outcomes (1)
Adverse events
Up to 4 hours after start of infusion
Study Arms (3)
100 mg IV
OTHER100 mg IV lacosamide infused over 30 minutes
200 mg IV
OTHER200 mg IV lacosamide infused over 30 minutes
400 mg IV
OTHER400 mg IV lacosamide infused over 30 minutes
Interventions
Eligibility Criteria
You may qualify if:
- Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
- Adult patients 18-65 years
- Diagnosis of focal epilepsy
- Continuous EEG and video monitoring
- Continuous EKG
- Active EEG showing frequent spikes, electrographic or clinical seizures
You may not qualify if:
- Subject has no IV access.
- Subject is hemodynamically unstable.
- Previous use of Lacosamide
- Primary generalized epilepsy
- Non-epileptic seizures
- No significant cardiac, renal or hepatic disease
- No cardiac arrhythmias including heart block
- Subject is a pregnant or lactating woman.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Foothills Medical Center
Calgary, Alberta, T2N 2T9, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard McLachlan, MD, FRCPC
London Health Sciences Centre, University Campus
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 31, 2012
First Posted
November 12, 2012
Study Start
May 1, 2013
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
September 26, 2016
Record last verified: 2016-09