Focal EpilepsyPhase 2LIVENCT01724918
Lacosamide IV and EEG/EKG (LIVE) Study
A Phase 2 study testing Lacosamide in people with Focal Epilepsy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Focal Epilepsy
- What is being tested?
- Lacosamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesCanada
- Study dates
- May 2013to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Foothills Medical Center
Calgary, Alberta, T2N 2T9
London Health Sciences Centre
London, Ontario, N6A 5A5
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
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.
Read the 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.
- Conditions
- Focal Epilepsy
- Being tested
- Lacosamide
- Keywords
- IV lacosamide, focal epilepsy, EEG, EKG
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacosamideDrug
Also called Vimpat
| Study group | Role | What they receive |
|---|---|---|
| 100 mg IV | Other | 100 mg IV lacosamide infused over 30 minutes Receives: Drug: Lacosamide |
| 200 mg IV | Other | 200 mg IV lacosamide infused over 30 minutes Receives: Drug: Lacosamide |
| 400 mg IV | Other | 400 mg IV lacosamide infused over 30 minutes Receives: Drug: Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of interictal spikes
Measured: One hour before and after drug
Secondary outcomes (2)
Change in frequency and quantity of background EEG rhythms
Measured: One hour before and after drug
Change in EKG (QT, PR interval and heart rhythm)
Measured: One hour before and after drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startMay 2013
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Time limitation for recruitment exceeded. 72 of 90 estimated sample recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma GmbH
- Responsible party
- Principal investigator, Rick McLachlan, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Richard McLachlan, MD, FRCPC, Principal investigator, London Health Sciences Centre, University Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724918
- Sponsor's protocol ID
- LIVE 001
- Acronym
- LIVE
- Status last verified
- Sep 2016
- First submitted
- 31 Oct 2012
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lacosamide IV and EEG/EKG (LIVE) Study
- ClinicalTrials.gov ID
- NCT01724918
- Acronym / sponsor ID
- LIVE / LIVE 001
- Conditions
- Focal Epilepsy
- Keywords
- IV lacosamide, focal epilepsy, EEG, EKG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Time limitation for recruitment exceeded. 72 of 90 estimated sample recruited.
- Enrolment
- 72 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- UCB Pharma GmbH
- Study start
- May 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 12 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 100 mg IV | Other | Drug: Lacosamide100 mg IV lacosamide infused over 30 minutes |
| 200 mg IV | Other | Drug: Lacosamide200 mg IV lacosamide infused over 30 minutes |
| 400 mg IV | Other | Drug: Lacosamide400 mg IV lacosamide infused over 30 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Subject has no IV access.
- Subject is hemodynamically unstable.
- Previous use of Lacosamide
- Primary generalized epilepsy
- Non-epileptic seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LacosamideAlso: Vimpat | Drug | 100 mg IV, 200 mg IV, 400 mg IV |
Primary outcome
Change in the number of interictal spikes
Time frame: One hour before and after drug
2 secondary outcomes
Change in frequency and quantity of background EEG rhythms
Time frame: One hour before and after drug
Change in EKG (QT, PR interval and heart rhythm)
Time frame: One hour before and after drug
Results and safety
The study was stopped early (reason given: Time limitation for recruitment exceeded. 72 of 90 estimated sample recruited.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard McLachlan, MD, FRCPC principal investigator
London Health Sciences Centre, University Campus
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lacosamide in people with Focal Epilepsy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Time limitation for recruitment exceeded. 72 of 90 estimated sample recruited.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of interictal spikes (time frame: One hour before and after drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2016.