A Pharmacogenomic Exploration of Lacosamide Response
Recruitment status was: Recruiting
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|
|Official Title:||A Pharmacogenomic Exploration of Lacosamide Response|
- Seizure frequency [ Time Frame: Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period ] [ Designated as safety issue: No ]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.
- Maintenance dose [ Time Frame: Recorded every three months for an 18 month period ] [ Designated as safety issue: No ]Maintenance dose will be defined as the tolerated daily dose required by the patient for seizure control.
- Adverse drug reactions [ Time Frame: Recorded as reaction arise during the 18 month study period ] [ Designated as safety issue: Yes ]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.
Biospecimen Retention: Samples With DNA
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399528
|United States, North Carolina|
|Duke Medical Centre|
|Durham, North Carolina, United States|
|Dublin, Ireland, D4|
|The Institute of Neurology|
|London, United Kingdom|
|Principal Investigator:||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|