Studying biomarkers to predict epilepsy treatment outcomes in people with epilepsy
Looks for markers that predict epilepsy treatment results in people newly diagnosed with epilepsy.
Plain-language title generated from the registry record
Registry title: Precision Medicine in the Treatment of Epilepsy
Key facts
- Where
- Copenhagen, DenmarkSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 55 years old?
Source: NCT05450822, who can take part
Where in Denmark
- Neurobiology Research Unit, RigshospitaletCopenhagen, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gitte Moos Knudsen
- Trial code
- NCT05450822
- Record updated
- 11 April 2024
- Original description
Primary objectives:Read full original descriptionShow less
The BrainDrugs-Epilepsy Study: A Prospective Open-label Cohort Precision Medicine Study in Epilepsy
Primary objectives:
The purpose of this study is to identify single and composite biomarkers (from neuroimaging, electrophysiological, and non-imaging biological measures), clinical measures (from cognitive, psychometric, and behavioral test scores), and risk/protective factors (e.g., from medical history, socioeconomic status, coping, lifestyle) that can:
1. Predict antiseizure medication (ASM) treatment outcome, psychiatric, cognitive, or behavioral comorbidities, and quality of life in newly diagnosed epilepsy patients (Cohort II-III). 2. Predict a second epileptic seizure/epilepsy diagnosis and behavioral, cognitive, psychiatric dysfunction and quality of life in patients after a first epileptic seizure (Cohort I).
Inclusion: No history of current or past psychiatric or other major medical conditions; Cohort I-II: Age between 16 and 55 years; Cohort III: Age between 18 and 55 years; Cohort I: Semiology of first seizure raises a strong suspicion of epilepsy but do not fulfill International League Against Epilepsy (ILAE) diagnostic criteria; Cohort II-III: Diagnosed with epilepsy according to ILAE criteria; Cohort III: Epileptogenic lesion on MRI concordant with seizure semiology and/or EEG.
Exclusion: Current or previous neurological disease, severe somatic disease, or consumption of medical drugs likely to influence the test results; Contraindications for MRI (pacemaker, metal implants, etc.); Alcohol or drug abuse; Drug use other than tobacco and alcohol within the last 30 days; Drugs > 10 x lifetime (for each substance); Current psychoactive medication; Cohort I-III: Medication incompatible with study aims or causing interactions with the administered levetiracetam or lamotrigine therapy (e.g., SV2A binding agents, monoamine oxidase inhibitors, fluvoxamin, methotrexate, benzodiazepines, phenobarbital, carbamazepine, valproate, regular use of other ASMs); Contraindication for MRI (e.g., magnetic implants, pacemaker); Cohort I-III: Current or previous alcohol or drug abuse; Any current or former primary psychiatric disorder (Axis I WHO ICD-10 diagnostic classification); Cohort I-III: Known genetic syndromes, psychomotor retardation or disease associated with gross morphological brain changes such as brain tumor, major stroke or major traumatic brain injury; Cohort I-III: Reduced kidney function (i.e., glomerular filtration rate (GFR) < 80 ml/min or 50 ml/min for patients 16-17 years old or ≥18 years old, respectively),; Cohort I-III: Cardiac conduction disorders (e.g., Brugada syndrome, long QT-syndrome); Cohort I-III: Life expectancy < 10 years; Non-fluent in Danish or pronounced visual or auditory impairments; Current or past learning disability; Pregnancy or lactation (females); Participation in experiments with radioactivity (>10 mSv) within the last year or significant occupational exposure to radioactivity; Severe head injury; Hash > 50 x lifetime; Cohort I-III: Body weight less than 40 kg; Cohort I-III: Moderate reduced liver function; Inability to complete PET (Cohort III) or MRI scans (Cohort I-III) (e.g., claustrophobia, issues with back pain); Cohort III: Exposure to radioactivity >10 mSv within the last year or significant occupational exposure to radioactivity; Pregnancy or lactation; Cohort I-III: Non-fluency in Danish or pronounced visual or auditory impairments or severe intellectual disability.