Using precision medicine to improve epilepsy treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify biomarkers and clinical measures that can predict treatment outcomes and quality of life in patients with epilepsy. It involves three cohorts: patients with a first seizure, newly diagnosed epilepsy patients, and a subset undergoing advanced neuroimaging. Participants will be monitored over time as they begin treatment with antiseizure medications, with data collected through clinical assessments and a mobile app for ongoing monitoring. The study seeks to enhance understanding of epilepsy and improve personalized treatment approaches.

Why it matters

Who can join: the full rules

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

Where it's running

• Neurobiology Research Unit, Rigshospitalet
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Lars Hageman Pinborg, MD — Neurobiological Research Unit
• Study coordinator: Maja Marstrand-Jørgensen, MD
• Email: maja.marstrand-jorgensen@nru.dk
• Phone: +45 35 45 36 43

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.