NCT01399528

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 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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
660

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
4 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 7, 2012

Status Verified

December 1, 2012

Enrollment Period

2.5 years

First QC Date

July 20, 2011

Last Update Submit

December 5, 2012

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Seizure frequency

    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.

    Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period

Secondary Outcomes (2)

  • Maintenance dose

    Recorded every three months for an 18 month period

  • Adverse drug reactions

    Recorded as reaction arise during the 18 month study period

Study Arms (5)

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with epilepsy recruited from five tertiary referral centres.

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Duke Medical Centre

Durham, North Carolina, United States

RECRUITING

Hospital Erasme

Brussels, Belgium

RECRUITING

Beaumont Hospital

Dublin, Dublin, D4, Ireland

RECRUITING

St.James Hospital

Dublin, Ireland

RECRUITING

The Institute of Neurology

London, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Collecting DNA from blood samples

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianpiero Cavalleri, PhD

CONTACT

+353 1 4022146gcavalleri@rcsi.ie

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Neurologist

Study Record Dates

First Submitted

July 20, 2011

First Posted

July 21, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 7, 2012

Record last verified: 2012-12

Locations

GB(1)US(1)BE(1)IE(2)