A Pharmacogenomic Exploration of Lacosamide Response
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
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Brussels, Belgien
- Rekrytering
- Hospital Erasme
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Kontakt:
- Chantal Depondt
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North Carolina
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Durham, North Carolina, Förenta staterna
- Rekrytering
- Duke Medical Centre
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Kontakt:
- Saraubh Sinha
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Dublin, Irland, D4
- Rekrytering
- Beaumont Hospital
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Kontakt:
- Gianpiero Cavalleri, PhD
- Telefonnummer: +353 1 4022146
- E-post: gcavalleri@rcsi.ie
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Huvudutredare:
- Norman Delanty
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Dublin, Irland
- Rekrytering
- St.James Hospital
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Kontakt:
- Colin Doherty
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London, Storbritannien
- Rekrytering
- The Institute of Neurology
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Kontakt:
- Sanjay Sisodiya
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Beaumont Hospital, Dublin, Ireland
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St. James' Hospital, Dublin, Ireland
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Hôpital Erasme, Brussels, Belgium
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Duke Medical Centre, North Carolina, USA
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The Institute of Neurology/University College London, UK
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Seizure frequency
Tidsram: Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period
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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.
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Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Maintenance dose
Tidsram: Recorded every three months for an 18 month period
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Maintenance dose will be defined as the tolerated daily dose required by the patient for seizure control.
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Recorded every three months for an 18 month period
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Adverse drug reactions
Tidsram: Recorded as reaction arise during the 18 month study period
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We will record any adverse reactions recorded by the study participant, including for example (but not limited to): dizziness, ataxia, vomiting, diplopia, nausea, vertigo, and vision blurred.
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Recorded as reaction arise during the 18 month study period
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Norman Delanty, MB FRCPI, Beaumont Hospital and Royal College of Surgeons in Ireland
- Huvudutredare: Gianpiero L Cavalleri, PhD, Royal College of Surgeons in Ireland
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RCSI_LCM
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