A Pharmacogenomic Exploration of Lacosamide Response
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|ClinicalTrials.gov Identifier: NCT01399528|
Recruitment Status : Unknown
Verified December 2012 by Norman Delanty, Royal College of Surgeons, Ireland.
Recruitment status was: Recruiting
First Posted : July 21, 2011
Last Update Posted : December 7, 2012
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
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||660 participants|
|Official Title:||A Pharmacogenomic Exploration of Lacosamide Response|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||March 2014|
|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|
- 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.
- Maintenance dose [ Time Frame: Recorded every three months for an 18 month period ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399528
|Contact: Gianpiero Cavalleri, PhD||+353 1 firstname.lastname@example.org|
|United States, North Carolina|
|Duke Medical Centre||Recruiting|
|Durham, North Carolina, United States|
|Contact: Saraubh Sinha|
|Contact: Chantal Depondt|
|Dublin, Ireland, D4|
|Contact: Gianpiero Cavalleri, PhD +353 1 4022146 email@example.com|
|Principal Investigator: Norman Delanty|
|Contact: Colin Doherty|
|The Institute of Neurology||Recruiting|
|London, United Kingdom|
|Contact: Sanjay Sisodiya|
|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|