Status:
UNKNOWN
A Pharmacogenomic Exploration of Lacosamide Response
Lead Sponsor:
Royal College of Surgeons, Ireland
Collaborating Sponsors:
St. James's Hospital, Ireland
University College, London
Conditions:
Epilepsy
Eligibility:
All Genders
18-65 years
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT01399528
Start Date
September 1 2011
End Date
March 1 2014
Last Update
December 7 2012
Active Locations (5)
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1
Duke Medical Centre
Durham, North Carolina, United States
2
Hospital Erasme
Brussels, Belgium
3
Beaumont Hospital
Dublin, Dublin, Ireland, D4
4
St.James Hospital
Dublin, Ireland