NCT05450822Recruiting
Precision Medicine in the Treatment of Epilepsy
The BrainDrugs-Epilepsy Study: A Prospective Open-label Cohort Precision Medicine Study in Epilepsy
Source: ClinicalTrials.gov · Last updated 11 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 550 (estimated)
- First submitted
- 5 Jul 2022
- Start date
- 18 Feb 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Gitte Moos Knudsen
- Diseases
- Epilepsy
- NCT number
- NCT05450822
What you commit to
- Study type: Observational
- Planned participants: 550
- From 18 Feb 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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)
Age
- Cohort I-III: Life expectancy \< 10 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 16 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurobiology Research Unit, Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.