Recruiting

Lacosamide

Sponsor:

Royal College of Surgeons, Ireland

Code:

NCT01399528

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Study Details

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

Conditions

Epilepsy

Study ID

NCT01399528

Start date

Sep, 2011

Status verified date

Dec, 2012

Completion date

Mar, 2014

Anticipated

Primary completion date

Mar, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

660 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Seizure frequency [ Time Frame: Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period ]

Central Contacts and Locations

Central contacts

Gianpiero Cavalleri, PhD

+353 1 4022146gcavalleri@rcsi.ie

Locations

Duke Medical Centre

Recruiting

Durham, North Carolina, United States

More Information

Sponsor

Royal College of Surgeons, Ireland

Last update posted

Dec 7, 2012

Last verified

Dec, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Royal College of Surgeons, Ireland on 2012-12-07.