A Pharmacogenomic Exploration of Lacosamide Response
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | September 2011 |
| End Date: | March 2014 |
| Contact: | Gianpiero Cavalleri, PhD |
| Email: | gcavalleri@rcsi.ie |
| Phone: | +353 1 4022146 |
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
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
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
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