Precision Medicine in the Treatment of Epilepsy

Plain-language summary

This study explores personalized approaches in the treatment of epilepsy and evaluates the medicines Levetiracetam and Lamotrigine. It enrolls healthy volunteers as well as people aged 16-55 who have epilepsy or whose first seizure raises a strong suspicion of it. It is a study without a phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Gitte Moos Knudsen

Intervention

Levetiracetam, Levetiracetam Tablets, Lamotrigine tablet

Start date

2/18/2022

Estimated completion

12/31/2031

Countries

Denmark

Related genes

Locations

• Copenhagen, Denmark

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria for healthy subjects:

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

Exclusion Criteria for healthy subjects:

* 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.)
* 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)

Inclusion Criteria for patients:

* 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

Exclusion criteria for patients:

* 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