Actively Recruiting
Precision Medicine in the Treatment of Epilepsy
Led by Gitte Moos Knudsen · Updated on 2024-04-11
550
Participants Needed
1
Research Sites
514 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Precision Medicine in the Treatment of Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cohort I-II: Age between 16 and 55 years
- Cohort III: Age between 18 and 55 years
- Cohort I: First seizure with strong suspicion of epilepsy but not fulfilling epilepsy diagnostic criteria
- Cohort II-III: Diagnosed with epilepsy according to International League Against Epilepsy criteria
- Cohort III: Epileptogenic lesion on MRI matching seizure symptoms
- Healthy subjects: No history of current or past psychiatric or major medical conditions
You will not qualify if you...
- Life expectancy less than 10 years (Cohorts I-III)
- Known genetic syndromes, psychomotor retardation, or diseases causing major brain changes (e.g., tumor, stroke, severe injury) (Cohorts I-III)
- Body weight less than 40 kg (Cohorts I-III)
- Reduced kidney function below specified thresholds (Cohorts I-III)
- Moderate reduced liver function (Cohorts I-III)
- Cardiac conduction disorders such as Brugada syndrome or long QT syndrome (Cohorts I-III)
- Medications interfering with levetiracetam or lamotrigine treatment or study aims (Cohorts I-III)
- Contraindications for MRI (e.g., pacemaker, metal implants)
- Inability to complete PET (Cohort III) or MRI scans due to claustrophobia or back pain
- Exposure to high levels of radioactivity within the last year (Cohort III)
- Pregnancy or breastfeeding
- Non-fluency in Danish or severe sensory impairments or intellectual disability (Cohorts I-III)
- Current or past alcohol or drug abuse (Cohorts I-III)
- Current or previous neurological disease, severe somatic disease, or drug use likely to affect test results (healthy subjects)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Neurobiology Research Unit, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
M
Maja Marstrand-Jørgensen, MD
CONTACT
L
Lars Hageman Pinborg, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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