EpilepsyBDENCT05450822

Precision Medicine in the Treatment of Epilepsy

An observational study of Epilepsy, run by Gitte Moos Knudsen at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial 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… Read more about this study

Who is it for?: Ages 16 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Epilepsy
What is being tested?: Levetiracetam, Levetiracetam Tablets and Lamotrigine tablet
Type of treatment: Pill or oral medicine, Injection or infusion
How many people: 550 participants
Where: 1 siteDenmark
Study dates: 18 Feb 2022to 31 Dec 2031
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 55 years
All sexes
Healthy volunteers accepted
Child, Adult

Study population: This study consists of three patients cohorts: In Cohort I, we will include a total of 200 patients (≥16 years old) who have been referred to clinical care after experiencing their first epileptic seizure, but do not fulfill the diagnostic criteria for epilepsy. In Cohort II, we will include a total of 150 newly diagnosed epilepsy patients (≥16 years old), with the expectation that at least 70 patients from Cohort I will move into Cohort II during the observational period. Additionally, a subset of approximately 45 adult patients (≥18 years old) from Cohort II with focal onset seizures will be enrolled in Cohort III. We will also collect data from 50 healthy subjects to compare group differences at baseline.

Who may be able to join

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

Who cannot join

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.)

Show all 26Show fewer

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)
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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maja Marstrand-Jørgensen, MD contact

+45 35 45 36 43

maja.marstrand-jorgensen@nru.dk

Lars Hageman Pinborg, MD contact

+45 35 45 67 12

lars.pinborg@nru.dk

Denmark1 site, 1 recruiting

Neurobiology Research Unit, Rigshospitalet
Copenhagen, 2100
Gitte M Knudsen, DMSc, +45 35456720, gmk@nru.dk
Lars H. Pinborg, DMSc
Recruiting

Other trials in Denmark

About this study

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

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).

Read the 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.

Data from healthy controls will be collected, the investigative program for whom will be similar to that of Cohort III.

After completing the baseline investigation program, patients diagnosed with epilepsy will start ASM treatment with lamotrigine or levetiracetam, in accordance with standard treatment procedures. If the first ASM does not lead to seizure-freedom, the patients will be offered to switch to the other. Patients will be monitored every three months in the epilepsy outpatient clinic or by video or telephone consultations. For daily monitoring, a digital solution will be used, including a mobile app for patients and a web dashboard for health professionals

The mobile app contains a study module with content tailor-made for the BrainDrugs Epilepsy Study. Patients will be instructed to use the app once daily to register compliance and disease progression. Patients will complete monthly questionnaires (NDDI-E, GAD-7, LAEP, PGIC, SSQ, STAXI-2 and WHO-5) through the app tracking depressive symptoms, anxiety, adverse reactions, treatment response, seizure frequency and severity, aggression, and quality of life.

The investigators aim to include a total of 350 patients and 50 healthy subjects during the first three years of the study. All patients will be followed for five years. In addition, data from Danish health registries and electronic patient records will be used to characterize patients both retrospectively (e.g., information about birth complications) and prospectively (e.g., clinical status) during the study period.

In Cohort I, investigators will include a total of 200 patients (≥16 years old) who have been referred to clinical care after experiencing their first epileptic seizure, but do not fulfil the diagnostic criteria for epilepsy. In Cohort II, investigators will include a total of 150 newly diagnosed patients with epilepsy (≥16 years old). During the observational period, investigators expect at least 70 patients from Cohort I to be diagnosed with epilepsy upon experiencing their second epileptic seizure. These patients will subsequently be included in Cohort II. Lastly, Cohort III will be a subset of approximately 45 adult patients (≥18 years old) from Cohort II with focal onset seizures who will undergo investigation with PET.

After inclusion in the study, the patients will undergo an examination program at baseline and follow-up (1, 3 and 5 years after inclusion) that includes a study nurse interview with setup of the mobile app, neuropsychiatric interview and examination, neuropsychological tests and self-report questionnaires, high density EEG, MRI brain scan including (T1, T2, fluid-attenuated inversion recovery (FLAIR), diffusion tensor imaging (DTI), arterial spin labeling (ASL) and functional magnetic resonance imaging (fMRI)) and blood and urine samples as well as gut microbiome samples (Cohort II-III). In addition, adult patients in Cohort III will undergo a [11C]-UCB-J PET brain scan followed by intravenous administration of levetiracetam (LEV) in a displacement paradigm.

For patients in Cohort III treated with LEV, if both symptoms and extended examinations are compatible with either 1) the development of an epilepsy-related comorbidity, 2) clinically significant adverse reactions or adverse events, 3) drug treatment failure, or 4) drug resistance, a repeated [11C]-UCB-J PET brain scan will be acquired prior to change in ASM treatment.

After inclusion in the study all healthy controls (HCs) will undergo an examination program similar to Cohort III. HCs will not be followed over time. The mobile app will only be used by patients.

Primary hypotheses:

Combined biomarkers from morphometric measurements (e.g., the volume of thalamus and hippocampus, cortical thickness of precentral gyri, parahippocampal cortex, entorhinal and fusiform gyri, precuneus, frontal gyri), within-network resting-state functional connectivity (rsfMRI), whole-brain structural connectomics (Diffusion Tensor Imaging, DTI) and functional connectivity in the theta band (EEG) at baseline can be used to predict the chance of a recurrent seizure (Cohort I).
Combined biomarkers from morphometric measurements (e.g., the volume of amygdala and hippocampus, cortical thickness of orbitofrontal cortex), resting-state functional connectivity in the anterior cingulate cortex, between prefrontal-limbic systems, angular gyrus, temporal lobe, precuneus, cerebellum, default mode network, and executive control network (rsfMRI), structural connectivity between temporal lobe, the limbic system and orbitofrontal cortex (DTI) and functional connectivity in the anterior cingulate cortex, frontal and occipital alpha asymmetry and theta current source density in the anterior cingulate cortex (EEG) at epilepsy diagnosis can be used to predict the risk of developing drug-failure and epilepsy-related comorbidities (Cohort II-III).
Cerebral [11C]-UCB-J binding at baseline both globally and in primary volumes of interest, i.e., hippocampus, entorhinal cortex, fusiform gyrus, dorsolateral prefrontal cortex, ventrolateral prefrontal cortex, orbitofrontal cortex, striatum, anterior cingulate cortex and amygdala correlate negatively with epilepsy-related comorbidities e.g., depressive episodes and cognitive deficits (Cohort III and healthy).
Cerebral [11C]-UCB-J PET SV2A occupancy following a displacement paradigm with levetiracetam is associated with a decrease in cerebral blood flow in the epileptogenic lesions(s) (patients) and in primary volumes of interest, i.e., hippocampus, entorhinal cortex, fusiform gyrus, dorsolateral prefrontal cortex, ventrolateral prefrontal cortex, orbitofrontal cortex, striatum, anterior cingulate, and amygdala cortex in healthy controls and in patients who become seizure free with levetiracetam treatment (Cohort III and healthy).

Conditions: Epilepsy
Being tested: Levetiracetam, Levetiracetam Tablets, Lamotrigine tablet
Keywords: epilepsy, precision medicine, treatment targets, biomarkers, high density EEG, gut microbiome, longitudinal, levetiracetam, lamotrigine, neuroimaging, machine learning, treatment response, PET, MRI, Psychometrics
Medical subject headings: Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LevetiracetamDrug
Also called [11C]-UCB-J PET-MR scan
Healthy subjects and patients in Cohort III will undergo a 120 min. [11C]-UCB-J PET-MR brain scan followed by intravenous administration of levetiracetam after approx. 60 min. in a displacement paradigm. Before, during and after the intervention arterial spin labeling and resting-state functional MRI will be acquired.
To measure the radiolabelled tracer's arterial input function, including its radiolabelled metabolites, blood samples will be drawn during the PET scan from an arterial catheter.
The selected regions for the primary analyses are the epileptogenic lesion(s) (patients) and the neocortex, hippocampus, entorhinal cortex, fusiform gyrus, dorsolateral prefrontal cortex, ventrolateral prefrontal cortex, orbitofrontal cortex, striatum, anterior cingulate cortex and amygdala. [11C]-UCB-J binding, volume of distribution and SV2A occupancy will be quantified by analyzing the PET images with well-validated kinetic models.
Levetiracetam TabletsDrug
Also called Levetiracetam
Patients in Cohort II will be randomized to treatment with an ASM (levetiracetam) in accordance with standard treatment procedures. The patients will enter a 4 weeks titration period receiving increasing doses. During weeks 5-30, patients will enter an evaluation period where the dose can be increased (continued seizures) or decreased (adverse reactions). In cases of unacceptable seizure control and/or intolerable adverse reactions; shift to lamotrigine arm.
Lamotrigine tabletDrug
Also called Lamotrigine
Patients in Cohort II will be randomized to treatment with an ASM (lamotrigine) in accordance with standard treatment procedures. The patients will enter a 6 weeks titration period receiving increasing doses. During weeks 5-30, patients will enter an evaluation period where the dose can be increased (continued seizures) or decreased (adverse reactions). In cases of unacceptable seizure control and/or intolerable adverse reactions; shift to levetiracetam arm.

Study groups in NCT05450822
Study group	Role	What they receive
Healthy Controls		Healthy volunteers with no pre-existing or current psychiatric, neurological or server somatic illness. Receives: Drug: Levetiracetam
Cohort I		Patients who have a history of only one epileptic seizure.
Cohort II		Patients who are newly diagnosed with epilepsy. Receives: Drug: Levetiracetam Tablets; Drug: Lamotrigine tablet
Cohort III		Patients who are newly diagnosed with epilepsy and have an epileptogenic lesion on MRI concordant with seizure semiology and/or EEG. Receives: Drug: Levetiracetam

What is being measured

The primary outcome is the main question the study is designed to answer.

Categorical effect of anti-seizure medication (ASM) on treatment outcome (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.
Measured: 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.
Categorical effect of a second seizure/epilepsy diagnosis for patients in Cohort I.
The proportion of patients in Cohort I with one epileptic seizure who become diagnosed with epilepsy.
Measured: As change over time of epilepsy diagnosis at six months, one, three and five years after inclusion of patients in Cohort I.

Secondary outcomes (19)

Continuous treatment outcome using a seizure severity index (Cohort II-III).
Treatment outcome as percentage change in the Seizure Severity Questionnaire (SSQ).
Measured: 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.
Continuous treatment outcome rating adverse events (Cohort II-III).
Treatment outcome as percentage change in the Liverpool Adverse Event Profile (LAEP).
Measured: 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 impression of change (Cohort II-III).
Treatment outcome as percentage change in in Patient's Global Impression of Change (PGIC).
Measured: 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 depression diagnosis (Cohort I-III and healthy).
Percentage change in Major Depression Inventory (MDI).
Measured: 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).
Percentage change in Inventory of Depressive Symptomatology (IDS-SR30).
Measured: 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 specific depressive symptoms associated with neurological disease (Cohort I-III and healthy).
Percentage change in the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E).
Measured: 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).
Psychopathology assessed by WHO International Classification of Diseases 10 (ICD-10) diagnostic classification and a semi-structured psychiatric, clinical interview.
Measured: 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).
Percentage change in the Generalized Anxiety Disorder 7-item (GAD-7).
Measured: 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.
Performance in EMOTICOM Emotional Recognition Task (ERT-eyes) (Cohort I-III and healthy).
Differences between healthy controls and patients in recognizing facial expressions and emotions.
Measured: 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 Auditory Verbal Learning Test (RAVLT) (Cohort I-III and healthy).
Differences between healthy controls and patients in verbal learning and memory.
Measured: 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).
Differences between healthy controls and patients in executive function.
Measured: 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 D-KEFS Verbal Fluency (Fluency) (Cohort II-III and healthy).
Differences between healthy controls and patients in executive function.
Measured: 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 Wechsler Adult Intelligence Scale (WAIS-IV) (Cohort I-III and healthy).
Differences between healthy controls and patients in IQ and specific index scores measured as percentage change in Wechsler Adult Intelligence Scale (WAIS-IV).
Measured: 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).
Differences between healthy controls and patients in visio-spatial learning.
Measured: 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.
Performance in Boston Naming Test (BNT) (Cohort II-III and healthy).
Differences between patient cohorts in word-retrieval.
Measured: 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 Trail Making Test A & B (Trail A & B) (Cohort II-III and healthy).
Differences between patient cohorts in psychomotor speed.
Measured: 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 Quality of Life in Epilepsy (QUOLIE-31) (Cohort I-III and healthy).
Differences between healthy controls and patients in quality of life measured as percentage change in Quality of Life in Epilepsy (QUOLIE-31).
Measured: 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.
A continuous rating of Sheehans Disability Score (SDS) (Cohort I-III and healthy).
Differences between healthy controls and patients in quality of life measured as percentage change in Sheehans Disability Score (SDS).
Measured: 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).
Differences between healthy controls and patients in quality of life measured as percentage change in WHO 5 wellbeing index.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Feb 202231 Dec 2031

First posted11 Jul 2022
Study start18 Feb 2022
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (196)Papers the sponsor has linked to this study.
Other trials for EpilepsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 550 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05450822
Sponsor's protocol ID: H-21031962
Acronym: BDE
Status last verified: Apr 2024
First submitted: 5 Jul 2022
Last updated: 11 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Via database of Center for Integrated Molecular Brain Imaging (Knudsen et al 2016, NeuroImage) data will be available for the research community upon request and after approval by the scientific board at Neurobiological Research Unit. The data will be stored on a password protected survey system behind secure "firewalls" in accordance with the General Data Protection Regulation (GDPR, Regulation European Union (EU) 2016/679 April 27, 2016) and the Danish Data Protection Act and the regulation (Act No. 502 of 23 May 2018). Potential further processing in other national and international laboratories may occur, yet always in accordance with the GDPR (Regulation EU 2016/679 April 27, 2016) and the Danish Data Protection Act and the regulation (Act No. 502 of 23 May 2018).

Publications

Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshe SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709. Epub 2017 Mar 8.
PubMed 28276062
Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.
PubMed 24730690
Brodie MJ, Barry SJ, Bamagous GA, Norrie JD, Kwan P. Patterns of treatment response in newly diagnosed epilepsy. Neurology. 2012 May 15;78(20):1548-54. doi: 10.1212/WNL.0b013e3182563b19. Epub 2012 May 9.
PubMed 22573629
Perucca E. Antiepileptic drugs: evolution of our knowledge and changes in drug trials. Epileptic Disord. 2019 Aug 1;21(4):319-329. doi: 10.1684/epd.2019.1083.
PubMed 31403463
Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.
PubMed 10660394
Chung S, Wang N, Hank N. Comparative retention rates and long-term tolerability of new antiepileptic drugs. Seizure. 2007 Jun;16(4):296-304. doi: 10.1016/j.seizure.2007.01.004. Epub 2007 Jan 30.
PubMed 17267243
Marson A, Jacoby A, Johnson A, Kim L, Gamble C, Chadwick D; Medical Research Council MESS Study Group. Immediate versus deferred antiepileptic drug treatment for early epilepsy and single seizures: a randomised controlled trial. Lancet. 2005 Jun 11-17;365(9476):2007-13. doi: 10.1016/S0140-6736(05)66694-9.
PubMed 15950714
Kwan P, Brodie MJ. Effectiveness of first antiepileptic drug. Epilepsia. 2001 Oct;42(10):1255-60. doi: 10.1046/j.1528-1157.2001.04501.x.
PubMed 11737159
Leach JP, Brodie MJ. New antiepileptic drugs--an explosion of activity. Seizure. 1995 Mar;4(1):5-17. doi: 10.1016/s1059-1311(05)80074-3.
PubMed 7788108
Lynch BA, Lambeng N, Nocka K, Kensel-Hammes P, Bajjalieh SM, Matagne A, Fuks B. The synaptic vesicle protein SV2A is the binding site for the antiepileptic drug levetiracetam. Proc Natl Acad Sci U S A. 2004 Jun 29;101(26):9861-6. doi: 10.1073/pnas.0308208101. Epub 2004 Jun 21.
PubMed 15210974
Tomson T, Battino D, Perucca E. Teratogenicity of antiepileptic drugs. Curr Opin Neurol. 2019 Apr;32(2):246-252. doi: 10.1097/WCO.0000000000000659.
PubMed 30664067
Steiner TJ, Dellaportas CI, Findley LJ, Gross M, Gibberd FB, Perkin GD, Park DM, Abbott R. Lamotrigine monotherapy in newly diagnosed untreated epilepsy: a double-blind comparison with phenytoin. Epilepsia. 1999 May;40(5):601-7. doi: 10.1111/j.1528-1157.1999.tb05562.x.
PubMed 10386529
Marson AG, Al-Kharusi AM, Alwaidh M, Appleton R, Baker GA, Chadwick DW, Cramp C, Cockerell OC, Cooper PN, Doughty J, Eaton B, Gamble C, Goulding PJ, Howell SJ, Hughes A, Jackson M, Jacoby A, Kellett M, Lawson GR, Leach JP, Nicolaides P, Roberts R, Shackley P, Shen J, Smith DF, Smith PE, Smith CT, Vanoli A, Williamson PR; SANAD Study group. The SANAD study of effectiveness of carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate for treatment of partial epilepsy: an unblinded randomised controlled trial. Lancet. 2007 Mar 24;369(9566):1000-15. doi: 10.1016/S0140-6736(07)60460-7.
PubMed 17382827
Yatham LN, Kennedy SH, Parikh SV, Schaffer A, Bond DJ, Frey BN, Sharma V, Goldstein BI, Rej S, Beaulieu S, Alda M, MacQueen G, Milev RV, Ravindran A, O'Donovan C, McIntosh D, Lam RW, Vazquez G, Kapczinski F, McIntyre RS, Kozicky J, Kanba S, Lafer B, Suppes T, Calabrese JR, Vieta E, Malhi G, Post RM, Berk M. Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder. Bipolar Disord. 2018 Mar;20(2):97-170. doi: 10.1111/bdi.12609. Epub 2018 Mar 14.
PubMed 29536616
Solmi M, Veronese N, Zaninotto L, van der Loos ML, Gao K, Schaffer A, Reis C, Normann C, Anghelescu IG, Correll CU. Lamotrigine compared to placebo and other agents with antidepressant activity in patients with unipolar and bipolar depression: a comprehensive meta-analysis of efficacy and safety outcomes in short-term trials. CNS Spectr. 2016 Oct;21(5):403-418. doi: 10.1017/S1092852916000523.
PubMed 27686028

Interested in taking part?

Maja Marstrand-Jørgensen, MD

+45 35 45 36 43

maja.marstrand-jorgensen@nru.dk

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The BrainDrugs-Epilepsy Study: A Prospective Open-label Cohort Precision Medicine Study in Epilepsy
ClinicalTrials.gov ID: NCT05450822
Acronym / sponsor ID: BDE / H-21031962
Conditions: Epilepsy
Keywords: epilepsy, precision medicine, treatment targets, biomarkers, high density EEG, gut microbiome, longitudinal, levetiracetam
Study type: Observational
Recruitment status: Recruiting
Enrolment: 550 participants (estimated)
Lead sponsor: Gitte Moos KnudsenUniversity, hospital or other
Study start: 18 Feb 2022 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2031 (estimated)
First posted: 11 Jul 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary objectives:

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 III includes a subset of patients from Cohort II who they also undergo Positron Emission Tomography (PET) synaptic vesicle glycoprotein 2A (SV2A) neuroimaging.

Data from healthy controls will be collected, the investigative program for whom will be similar to that of Cohort III.

After inclusion in the study all healthy controls (HCs) will undergo an examination program similar to Cohort III. HCs will not be followed over time. The mobile app will only be used by patients.

Primary hypotheses:

Combined biomarkers from morphometric measurements (e.g., the volume of thalamus and hippocampus, cortical thickness of precentral gyri, parahippocampal cortex, entorhinal and fusiform gyri, precuneus, frontal gyri), within-network resting-state functional connectivity (rsfMRI), whole-brain structural connectomics (Diffusion Tensor Imaging, DTI) and functional connectivity in the theta band (EEG) at baseline can be used to predict the chance of a recurrent seizure (Cohort I).
Combined biomarkers from morphometric measurements (e.g., the volume of amygdala and hippocampus, cortical thickness of orbitofrontal cortex), resting-state functional connectivity in the anterior cingulate cortex, between prefrontal-limbic systems, angular gyrus, temporal lobe, precuneus, cerebellum, default mode network, and executive control network (rsfMRI), structural connectivity between temporal lobe, the limbic system and orbitofrontal cortex (DTI) and functional connectivity in the anterior cingulate cortex, frontal and occipital alpha asymmetry and theta current source density in the anterior cingulate cortex (EEG) at epilepsy diagnosis can be used to predict the risk of developing drug-failure and epilepsy-related comorbidities (Cohort II-III).
Cerebral [11C]-UCB-J binding at baseline both globally and in primary volumes of interest, i.e., hippocampus, entorhinal cortex, fusiform gyrus, dorsolateral prefrontal cortex, ventrolateral prefrontal cortex, orbitofrontal cortex, striatum, anterior cingulate cortex and amygdala correlate negatively with epilepsy-related comorbidities e.g., depressive episodes and cognitive deficits (Cohort III and healthy).
Cerebral [11C]-UCB-J PET SV2A occupancy following a displacement paradigm with levetiracetam is associated with a decrease in cerebral blood flow in the epileptogenic lesions(s) (patients) and in primary volumes of interest, i.e., hippocampus, entorhinal cortex, fusiform gyrus, dorsolateral prefrontal cortex, ventrolateral prefrontal cortex, orbitofrontal cortex, striatum, anterior cingulate, and amygdala cortex in healthy controls and in patients who become seizure free with levetiracetam treatment (Cohort III and healthy).

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
Healthy Controls	–	Drug: LevetiracetamHealthy 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	–	Drug: Levetiracetam Tablets, Drug: Lamotrigine tabletPatients who are newly diagnosed with epilepsy.
Cohort III	–	Drug: LevetiracetamPatients who are newly diagnosed with epilepsy and have an epileptogenic lesion on MRI concordant with seizure semiology and/or EEG.

Who may qualify

Ages: 16 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult
Study population: This study consists of three patients cohorts: In Cohort I, we will include a total of 200 patients (≥16 years old) who have been referred to clinical care after experiencing their first epileptic seizure, but do not fulfill the diagnostic criteria for epilepsy. In Cohort II, we will include a total of 150 newly diagnosed epilepsy patients (≥16 years old), with the expectation that at least 70 patients from Cohort I will move into Cohort II during the observational period. Additionally, a subset of approximately 45 adult patients (≥18 years old) from Cohort II with focal onset seizures will be enrolled in Cohort III. We will also collect data from 50 healthy subjects to compare group differences at baseline.

Key inclusion criteria (6 listed)

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

Key exclusion criteria (26 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LevetiracetamAlso: [11C]-UCB-J PET-MR scanHealthy subjects and patients in Cohort III will undergo a 120 min. [11C]-UCB-J PET-MR brain scan followed by intravenous administration of levetiracetam after approx. 60 min. in a displacement paradigm. Before, during and after the intervention arterial spin labeling and resting-state functional MRI will be acquired. To measure the radiolabelled tracer's arterial input function, including its radiolabelled metabolites, blood samples will be drawn during the PET scan from an arterial catheter. The selected regions for the primary analyses are the epileptogenic lesion(s) (patients) and the neocortex, hippocampus, entorhinal cortex, fusiform gyrus, dorsolateral prefrontal cortex, ventrolateral prefrontal cortex, orbitofrontal cortex, striatum, anterior cingulate cortex and amygdala. [11C]-UCB-J binding, volume of distribution and SV2A occupancy will be quantified by analyzing the PET images with well-validated kinetic models.	Drug	Cohort III, Healthy Controls
Levetiracetam TabletsAlso: LevetiracetamPatients in Cohort II will be randomized to treatment with an ASM (levetiracetam) in accordance with standard treatment procedures. The patients will enter a 4 weeks titration period receiving increasing doses. During weeks 5-30, patients will enter an evaluation period where the dose can be increased (continued seizures) or decreased (adverse reactions). In cases of unacceptable seizure control and/or intolerable adverse reactions; shift to lamotrigine arm.	Drug	Cohort II
Lamotrigine tabletAlso: LamotriginePatients in Cohort II will be randomized to treatment with an ASM (lamotrigine) in accordance with standard treatment procedures. The patients will enter a 6 weeks titration period receiving increasing doses. During weeks 5-30, patients will enter an evaluation period where the dose can be increased (continued seizures) or decreased (adverse reactions). In cases of unacceptable seizure control and/or intolerable adverse reactions; shift to levetiracetam arm.	Drug	Cohort II

Primary outcome

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.
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.

19 secondary outcomes

Continuous treatment outcome using a seizure severity index (Cohort II-III).
Time frame: 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.
Continuous treatment outcome rating adverse events (Cohort II-III).
Time frame: 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 impression of change (Cohort II-III).
Time frame: 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 depression diagnosis (Cohort I-III and healthy).
Time frame: 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).
Time frame: 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 specific depressive symptoms associated with neurological disease (Cohort I-III and healthy).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Performance in EMOTICOM Emotional Recognition Task (ERT-eyes) (Cohort I-III and healthy).
Time frame: 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 Auditory Verbal Learning Test (RAVLT) (Cohort I-III and healthy).
Time frame: 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).
Time frame: 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 D-KEFS Verbal Fluency (Fluency) (Cohort II-III and healthy).
Time frame: 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 Wechsler Adult Intelligence Scale (WAIS-IV) (Cohort I-III and healthy).
Time frame: 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).
Time frame: 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.
Performance in Boston Naming Test (BNT) (Cohort II-III and healthy).
Time frame: 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 Trail Making Test A & B (Trail A & B) (Cohort II-III and healthy).
Time frame: 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 Quality of Life in Epilepsy (QUOLIE-31) (Cohort I-III and healthy).
Time frame: 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.
A continuous rating of Sheehans Disability Score (SDS) (Cohort I-III and healthy).
Time frame: 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).
Time frame: 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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
Background: PubMed 28276062Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshe SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709. Epub 2017 Mar 8.
Background: PubMed 24730690Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.
Background: PubMed 22573629Brodie MJ, Barry SJ, Bamagous GA, Norrie JD, Kwan P. Patterns of treatment response in newly diagnosed epilepsy. Neurology. 2012 May 15;78(20):1548-54. doi: 10.1212/WNL.0b013e3182563b19. Epub 2012 May 9.
Background: PubMed 31403463Perucca E. Antiepileptic drugs: evolution of our knowledge and changes in drug trials. Epileptic Disord. 2019 Aug 1;21(4):319-329. doi: 10.1684/epd.2019.1083.
Background: PubMed 10660394Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.
Background: PubMed 17267243Chung S, Wang N, Hank N. Comparative retention rates and long-term tolerability of new antiepileptic drugs. Seizure. 2007 Jun;16(4):296-304. doi: 10.1016/j.seizure.2007.01.004. Epub 2007 Jan 30.
Background: PubMed 15950714Marson A, Jacoby A, Johnson A, Kim L, Gamble C, Chadwick D; Medical Research Council MESS Study Group. Immediate versus deferred antiepileptic drug treatment for early epilepsy and single seizures: a randomised controlled trial. Lancet. 2005 Jun 11-17;365(9476):2007-13. doi: 10.1016/S0140-6736(05)66694-9.
Background: PubMed 11737159Kwan P, Brodie MJ. Effectiveness of first antiepileptic drug. Epilepsia. 2001 Oct;42(10):1255-60. doi: 10.1046/j.1528-1157.2001.04501.x.
Background: PubMed 7788108Leach JP, Brodie MJ. New antiepileptic drugs--an explosion of activity. Seizure. 1995 Mar;4(1):5-17. doi: 10.1016/s1059-1311(05)80074-3.
Background: PubMed 15210974Lynch BA, Lambeng N, Nocka K, Kensel-Hammes P, Bajjalieh SM, Matagne A, Fuks B. The synaptic vesicle protein SV2A is the binding site for the antiepileptic drug levetiracetam. Proc Natl Acad Sci U S A. 2004 Jun 29;101(26):9861-6. doi: 10.1073/pnas.0308208101. Epub 2004 Jun 21.
Background: PubMed 30664067Tomson T, Battino D, Perucca E. Teratogenicity of antiepileptic drugs. Curr Opin Neurol. 2019 Apr;32(2):246-252. doi: 10.1097/WCO.0000000000000659.
Background: PubMed 10386529Steiner TJ, Dellaportas CI, Findley LJ, Gross M, Gibberd FB, Perkin GD, Park DM, Abbott R. Lamotrigine monotherapy in newly diagnosed untreated epilepsy: a double-blind comparison with phenytoin. Epilepsia. 1999 May;40(5):601-7. doi: 10.1111/j.1528-1157.1999.tb05562.x.
Individual participant dataSharing planned: Yes. Via database of Center for Integrated Molecular Brain Imaging (Knudsen et al 2016, NeuroImage) data will be available for the research community upon request and after approval by the scientific board at Neurobiological Research Unit. The data will be stored on a password protected survey system behind secure "firewalls" in accordance with the General Data Protection Regulation (GDPR, Regulation European Union (EU) 2016/679 April 27, 2016) and the Danish Data Protection Act and the regulation (Act No. 502 of 23 May 2018). Potential further processing in other national and international laboratories may occur, yet always in accordance with the GDPR (Regulation EU 2016/679 April 27, 2016) and the Danish Data Protection Act and the regulation (Act No. 502 of 23 May 2018).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Maja Marstrand-Jørgensen, MD contact

+45 35 45 36 43

maja.marstrand-jorgensen@nru.dk

Lars Hageman Pinborg, MD contact

+45 35 45 67 12

lars.pinborg@nru.dk

Lars Hageman Pinborg, MD principal investigator

Neurobiological Research Unit

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy, run by Gitte Moos Knudsen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maja Marstrand-Jørgensen, MD (+45 35 45 36 43, maja.marstrand-jorgensen@nru.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05450822, which also lists 196 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.