The BrainDrugs-Epilepsy Study: A Prospective Open-label Cohort Precision Medicine Study in Epilepsy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 55
Healthy Volunteers: t
View:

• No history of current or past psychiatric or other major medical conditions

• Cohort I-II: Age between 16 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

Locations
Other Locations
Denmark
Neurobiology Research Unit, Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Maja Marstrand-Jørgensen, MD
maja.marstrand-jorgensen@nru.dk
+45 35 45 36 43
Backup
Lars Hageman Pinborg, MD
lars.pinborg@nru.dk
+45 35 45 67 12
Time Frame
Start Date: 2022-02-18
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 550
Treatments
Healthy Controls
Healthy volunteers with no pre-existing or current psychiatric, neurological or server somatic illness.
Cohort I
Patients who have a history of only one epileptic seizure.
Cohort II
Patients who are newly diagnosed with epilepsy.
Cohort III
Patients who are newly diagnosed with epilepsy and have an epileptogenic lesion on MRI concordant with seizure semiology and/or EEG.
Related Therapeutic Areas
Sponsors
Leads: Gitte Moos Knudsen

This content was sourced from clinicaltrials.gov