NCT05450822 Precision Medicine in the Treatment of Epilepsy
| NCT ID | NCT05450822 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gitte Moos Knudsen |
| Condition | Epilepsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 550 participants |
| Start Date | 2022-02-18 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 550 participants in total. It began in 2022-02-18 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria for healthy subjects: * No history of current or past psychiatric or other major medical conditions Exclusion Criteria for healthy subjects: * Current or previous neurological disease, severe somatic disease, or consumption of medical drugs likely to influence the test results * 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 * Contraindications for MRI (pacemaker, metal implants, etc.) * Severe head injury * Alcohol or drug abuse * Drug use other than tobacco and alcohol within the last 30 days * Hash \> 50 x lifetime * Drugs \> 10 x lifetime (for each substance) * Current psychoactive medication * Any current or former primary psychiatric disorder (Axis I WHO ICD-10 diagnostic classification) Inclusion Criteria for patients: * 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 criteria for patients: * Cohort I-III: Life expectancy \< 10 years * 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: Body weight less than 40 kg * 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: Moderate reduced liver function * Cohort I-III: Cardiac conduction disorders (e.g., Brugada syndrome, long QT-syndrome) * 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) * 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 * Cohort I-III: Current or previous alcohol or drug abuse
Contact & Investigator
Lars Hageman Pinborg, MD
PRINCIPAL INVESTIGATOR
Neurobiological Research Unit
Frequently Asked Questions
Who can join the NCT05450822 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 55 Years, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05450822 currently recruiting?
Yes, NCT05450822 is actively recruiting participants. Contact the research team at maja.marstrand-jorgensen@nru.dk for enrollment information.
Where is the NCT05450822 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT05450822 clinical trial?
NCT05450822 is sponsored by Gitte Moos Knudsen. The principal investigator is Lars Hageman Pinborg, MD at Neurobiological Research Unit. The trial plans to enroll 550 participants.
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