Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
660 participants
OBSERVATIONAL
2011-09-30
2014-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Beaumont Hospital, Dublin, Ireland
No interventions assigned to this group
St. James' Hospital, Dublin, Ireland
No interventions assigned to this group
Hôpital Erasme, Brussels, Belgium
No interventions assigned to this group
Duke Medical Centre, North Carolina, USA
No interventions assigned to this group
The Institute of Neurology/University College London, UK
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
St. James's Hospital, Ireland
OTHER
University College, London
OTHER
Erasme University Hospital
OTHER
Duke University
OTHER
Royal College of Surgeons, Ireland
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Norman Delanty
Consultant Neurologist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Norman Delanty, MB FRCPI
Role: PRINCIPAL_INVESTIGATOR
Beaumont Hospital and Royal College of Surgeons in Ireland
Gianpiero L Cavalleri, PhD
Role: PRINCIPAL_INVESTIGATOR
Royal College of Surgeons in Ireland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Duke Medical Centre
Durham, North Carolina, United States
Hospital Erasme
Brussels, , Belgium
Beaumont Hospital
Dublin, Dublin, Ireland
St.James Hospital
Dublin, , Ireland
The Institute of Neurology
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Saraubh Sinha
Role: primary
Chantal Depondt
Role: primary
Gianpiero Cavalleri, PhD
Role: primary
Colin Doherty
Role: primary
Sanjay Sisodiya
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RCSI_LCM
Identifier Type: -
Identifier Source: org_study_id