EpilepsyNCT01399528
A Pharmacogenomic Exploration of Lacosamide Response
An observational study of Epilepsy, run by Royal College of Surgeons, Ireland at 5 sites in 4 countries.
Trial summary
This is an observational study exploring the genetics of lacosamide response. The study will last 3 years and has been divided in to three stages; 1) recruitment, 2) observational phase, 3) genotyping and analysis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- How many people
- 660 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Sep 2011to Mar 2014
- Phase
- Observational
- 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
Study population: patients with epilepsy recruited from five tertiary referral centres.
Who may be able to join
- Diagnosed with partial onset seizures (simple and/or complex) with or without secondary generalization (based on 1981 ILAE seizure classification scheme)
- Over 18 and under 65 years of age at date of recruitment in to the study
- Currently undergoing pharmacological treatment for refractory partial epilepsy ('refractory' here refers to patients who continue to have seizures despite treatment (current) with two or more appropriate anti-epileptic drugs at appropriate doses)
- Deemed suitable for treatment with lacosamide (following drug guidelines)
Who cannot join
- Patients experiencing seizure type other than partial onset seizures (with/without secondary generalisation)
- Patients with a history of chronic alcohol or drug abuse within previous 3 years.
- Non refractory epilepsy patients
- Patients suffering any other clinically significant disease e.g. cancers, progressive neurological disorder, heart failure, respiratory failure etc
- Patients who are pregnant or who are intending on getting pregnant within the period of the trial.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Ireland2 sites, 2 recruiting
- Recruiting
Beaumont Hospital
Dublin, Dublin, D4
Gianpiero Cavalleri, PhD, +353 1 4022146, gcavalleri@rcsi.ie
Norman Delanty
- Recruiting
St.James Hospital
Dublin
Colin Doherty
United States1 site, 1 recruiting
- Recruiting
Duke Medical Centre
Durham, North Carolina
Saraubh Sinha
United Kingdom1 site, 1 recruiting
- Recruiting
The Institute of Neurology
London
Sanjay Sisodiya
About this study
This is an observational study exploring the genetics of lacosamide response. The study will last 3 years and has been divided in to three stages; 1) recruitment, 2) observational phase, 3) genotyping and analysis. Patients initiating lacosamide are recruited and their baseline seizure frequency is assessed retrospectively. Patients are then monitored for 18 months with an assessment (via interview and where possible seizure diaries) of seizure frequency and other treatment related phenotypes every 3 months. The recruitment period will span months 1-12, the observational period will span months 1-30 and analysis of data will be conducted between months 30-36 (see Figure 2 below). Target sample size is 610.
Primary objective: To determine the clinical relevance of genetic variation in predicting lacosamide responsive and non-responsive patients.
Read more
Secondary objectives: To determine the clinical relevance of genetic variation in predicting:
- Optimal dose of lacosamide
- Adverse drug reactions to lacosamide
- Conditions
- Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Beaumont Hospital, Dublin, Ireland | Not described | |
| St. James' Hospital, Dublin, Ireland | Not described | |
| Hôpital Erasme, Brussels, Belgium | Not described | |
| Duke Medical Centre, North Carolina, USA | Not described | |
| The Institute of Neurology/University College London, UK | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency
We will record seizure type and frequency. Seizure types will follow definitions as provided by the International League Against Epilepsy. Seizure frequency will be as recorded by the participant in a seizure diary.
Measured: Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period
Secondary outcomes (2)
Maintenance dose
Maintenance dose will be defined as the tolerated daily dose required by the patient for seizure control.
Measured: Recorded every three months for an 18 month period
Adverse drug reactions
We will record any adverse reactions recorded by the study participant, including for example (but not limited to): dizziness, ataxia, vomiting, diplopia, nausea, vertigo, and vision blurred.
Measured: Recorded as reaction arise during the 18 month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- St. James's Hospital, Ireland, University College, London, Erasme University Hospital, Duke University
- Responsible party
- Principal investigator, Norman Delanty, Royal College of Surgeons, Ireland
- Investigators
- Norman Delanty, MB FRCPI, Principal investigator, Beaumont Hospital and Royal College of Surgeons in IrelandGianpiero L Cavalleri, PhD, Principal investigator, Royal College of Surgeons in Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399528
- Sponsor's protocol ID
- RCSI_LCM
- Status last verified
- Dec 2012
- First submitted
- 20 Jul 2011
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacogenomic Exploration of Lacosamide Response
- ClinicalTrials.gov ID
- NCT01399528
- Acronym / sponsor ID
- RCSI_LCM
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- St. James's Hospital, Ireland, University College, London, Erasme University Hospital, Duke University
- Study start
- Sep 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 21 Jul 2011 (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.
This is an observational study exploring the genetics of lacosamide response. The study will last 3 years and has been divided in to three stages; 1) recruitment, 2) observational phase, 3) genotyping and analysis. Patients initiating lacosamide are recruited and their baseline seizure frequency is assessed retrospectively. Patients are then monitored for 18 months with an assessment (via interview and where possible seizure diaries) of seizure frequency and other treatment related phenotypes every 3 months. The recruitment period will span months 1-12, the observational period will span months 1-30 and analysis of data will be conducted between months 30-36 (see Figure 2 below). Target sample size is 610.
Primary objective: To determine the clinical relevance of genetic variation in predicting lacosamide responsive and non-responsive patients.
Secondary objectives: To determine the clinical relevance of genetic variation in predicting:
- Optimal dose of lacosamide
- Adverse drug reactions to lacosamide
Study design
- Observational model
- Cohort
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Beaumont Hospital, Dublin, Ireland | – | – |
| St. James' Hospital, Dublin, Ireland | – | – |
| Hôpital Erasme, Brussels, Belgium | – | – |
| Duke Medical Centre, North Carolina, USA | – | – |
| The Institute of Neurology/University College London, UK | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with epilepsy recruited from five tertiary referral centres.
Key inclusion criteria (4 listed)
- Diagnosed with partial onset seizures (simple and/or complex) with or without secondary generalization (based on 1981 ILAE seizure classification scheme)
- Over 18 and under 65 years of age at date of recruitment in to the study
- Currently undergoing pharmacological treatment for refractory partial epilepsy ('refractory' here refers to patients who continue to have seizures despite treatment (current) with two or more appropriate anti-epileptic drugs at appropriate doses)
- Deemed suitable for treatment with lacosamide (following drug guidelines)
Key exclusion criteria (5 listed)
- Patients experiencing seizure type other than partial onset seizures (with/without secondary generalisation)
- Patients with a history of chronic alcohol or drug abuse within previous 3 years.
- Non refractory epilepsy patients
- Patients suffering any other clinically significant disease e.g. cancers, progressive neurological disorder, heart failure, respiratory failure etc
- Patients who are pregnant or who are intending on getting pregnant within the period of the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Seizure frequency
Time frame: Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period
We will record seizure type and frequency. Seizure types will follow definitions as provided by the International League Against Epilepsy. Seizure frequency will be as recorded by the participant in a seizure diary.
2 secondary outcomes
Maintenance dose
Time frame: Recorded every three months for an 18 month period
Adverse drug reactions
Time frame: Recorded as reaction arise during the 18 month study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2012.
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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.
Norman Delanty, MB FRCPI principal investigator
Beaumont Hospital and Royal College of Surgeons in Ireland
Gianpiero L Cavalleri, PhD principal investigator
Royal College of Surgeons in Ireland
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Royal College of Surgeons, Ireland at 5 sites in 4 countries.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ireland, United States, Belgium, United Kingdom. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gianpiero Cavalleri, PhD (+353 1 4022146, gcavalleri@rcsi.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure frequency (time frame: Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period). 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 7 Dec 2012.