The BrainDrugs-Epilepsy Study: A Prospective Open-label Cohort Precision Medicine Study in Epilepsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 550
- Locations
- 1
- Primary Endpoint
- Categorical effect of a second seizure/epilepsy diagnosis for patients in Cohort I.
Study Overview
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:
- Predict antiseizure medication (ASM) treatment outcome, psychiatric, cognitive, or behavioral comorbidities, and quality of life in newly diagnosed epilepsy patients (Cohort II-III).
- 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).
Detailed Description
Material and methods:
The BrainDrugs Epilepsy Study will be conducted as an open, longitudinal, prospective cohort study. The study consists of three patient cohorts:
Cohort I includes patients with a first epileptic seizure who will undergo basic clinical, cognitive, psychometric, and biological (blood) assessment, as well as electroencephalography (EEG) and Magnetic Resonance Imaging (MRI) neuroimaging.
Cohort II includes patients newly diagnosed with epilepsy who will undergo additional clinical, cognitive, psychometric, and biological (blood and stool) assessment as well as EEG and MRI neuroimaging.
Cohort III includes a subset of patients from Cohort II who they also undergo Positron Emission Tomography (PET) synaptic vesicle glycoprotein 2A (SV2A) neuroimaging.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 16 Years to 55 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Healthy Controls
Healthy volunteers with no pre-existing or current psychiatric, neurological or server somatic illness.
Intervention: Levetiracetam (Drug)
Cohort II
Patients who are newly diagnosed with epilepsy.
Intervention: Levetiracetam Tablets (Drug)
Cohort II
Patients who are newly diagnosed with epilepsy.
Intervention: Lamotrigine tablet (Drug)
Cohort III
Patients who are newly diagnosed with epilepsy and have an epileptogenic lesion on MRI concordant with seizure semiology and/or EEG.
Intervention: Levetiracetam (Drug)
Outcomes
Primary Outcomes
Categorical effect of a second seizure/epilepsy diagnosis for patients in Cohort I.
Time Frame: As change over time of epilepsy diagnosis at six months, one, three and five years after inclusion of patients in Cohort I.
The proportion of patients in Cohort I with one epileptic seizure who become diagnosed with epilepsy.
Categorical effect of anti-seizure medication (ASM) on treatment outcome (Cohort II-III).
Time Frame: As change over time from the ASM evaluation period (after 4-7 weeks titration period) to six months, one, three and five years after for patients in cohort II-III.
1) Seizure-free within six months after starting ASM treatment and remained seizure-free for at least one year (last observed seizure within the six months after starting ASM treatment); 2) Seizure-free more than six months after starting ASM treatment and the seizure-free period lasts at least one year; 3) Fluctuations with both seizure-freedom and seizure-relapse; or 4) Never seizure-free for a year at the third- and fifth-year follow-up timepoint.
Secondary Outcomes
- Continuous treatment outcome rating impression of change (Cohort II-III).(As a monthly change over time from the ASM evaluation period (after 4-7 weeks titration period) to one, three and five years after for patients in cohort II-III.)
- Performance in D-KEFS Verbal Fluency (Fluency) (Cohort II-III and healthy).(At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort II-III.)
- A continuous rating of Sheehans Disability Score (SDS) (Cohort I-III and healthy).(At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III.)
- A continuous rating of WHO 5 wellbeing index (WHO-5) (Cohort I-III and healthy).(At baseline between groups (HCs and patients) and as a monthly change over time from baseline and one, three and five years after inclusion for patients in cohort II-III.)
- Continuous treatment outcome rating adverse events (Cohort II-III).(As a monthly change over time from baseline and one, three and five years after inclusion for patients in cohort II-III.)
- A continuous rating of depression diagnosis (Cohort I-III and healthy).(At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III.)
- A continuous rating of depressive symptoms (Cohort I-III and healthy).(At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III.)
- A continuous rating of symptoms of anxiety (Cohort I-III and healthy).(At baseline between groups (HCs and patients) and as a monthly change over time from baseline to one, three and five years after inclusion for patients in cohort I-III.)
- Categorical outcome of psychiatric symptoms (Cohort I-III and healthy).(At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III.)
- Performance in Trail Making Test A & B (Trail A & B) (Cohort II-III and healthy).(At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort II-III.)
- Performance in Rey Auditory Verbal Learning Test (RAVLT) (Cohort I-III and healthy).(At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III.)
- Performance in D-KEFS Color-Word Interference Test (Stroop) (Cohort II-III and healthy).(At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort II-III.)
- Performance in Boston Naming Test (BNT) (Cohort II-III and healthy).(At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort II-III.)
- Continuous treatment outcome using a seizure severity index (Cohort II-III).(As a monthly change over time from the ASM evaluation period (after 4-7 weeks titration period) to one, three and five years after for patients in cohort II-III.)
- A continuous rating of specific depressive symptoms associated with neurological disease (Cohort I-III and healthy).(At baseline between groups (HCs and patients) and as a monthly change over time from baseline to one, three and five years after inclusion for patients in cohort I-III.)
- A continuous rating of Quality of Life in Epilepsy (QUOLIE-31) (Cohort I-III and healthy).(At baseline between groups (HCs and patients) and as change over time from baseline to 1, 3 and 5 years after inclusion for patients in cohort I-III.)
- Performance in EMOTICOM Emotional Recognition Task (ERT-eyes) (Cohort I-III and healthy).(At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III.)
- A continuous rating of Wechsler Adult Intelligence Scale (WAIS-IV) (Cohort I-III and healthy).(At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III.)
- Performance in Rey Complex Figure Test (RCFT) (Cohort II-III and healthy).(At baseline between groups (HCs and patients) and as change over time from baseline to 1, 3 and 5 years after inclusion for patients in cohort II-III.)
Investigators
Gitte Moos Knudsen
professor, MD neurology
Rigshospitalet, Denmark