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| Name | Class |
|---|---|
| St. James's Hospital, Ireland | OTHER |
| University College, London | OTHER |
| Erasme University Hospital | OTHER |
| Duke University |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance dose | Maintenance dose will be defined as the tolerated daily dose required by the patient for seizure control. | Recorded every three months for an 18 month period |
| Adverse drug reactions |
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Inclusion Criteria:
Exclusion Criteria:
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patients with epilepsy recruited from five tertiary referral centres.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gianpiero Cavalleri, PhD | Contact | +353 1 4022146 | gcavalleri@rcsi.ie |
| Name | Affiliation | Role |
|---|---|---|
| Norman Delanty, MB FRCPI | Beaumont Hospital and Royal College of Surgeons in Ireland | Principal Investigator |
| Gianpiero L Cavalleri, PhD | Royal College of Surgeons in Ireland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Medical Centre | Recruiting | Durham | North Carolina | United States |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
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Collecting DNA from blood samples
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.
| Recorded as reaction arise during the 18 month study period |
| Hospital Erasme | Recruiting | Brussels | Belgium |
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| Beaumont Hospital | Recruiting | Dublin | Dublin | D4 | Ireland |
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| St.James Hospital | Recruiting | Dublin | Ireland |
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| The Institute of Neurology | Recruiting | London | United Kingdom |
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