Epilepsy Trial, Recruiting NCT05450822 Sponsor: Gitte Moos Knudsen Condition: Epilepsy
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Epilepsy Trial, Recruiting

NCT05450822
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For healthy volunteers:

  • You have no history of mental health conditions or other major health problems

For patients (Cohort I – first seizure group):

  • You are between 16 and 55 years old
  • You have had a first seizure that strongly suggests epilepsy, but you do not yet fully meet the official diagnosis criteria for epilepsy

For patients (Cohort II – diagnosed epilepsy group):

  • You are between 16 and 55 years old
  • You have been officially diagnosed with epilepsy according to recognised international criteria

For patients (Cohort III – epilepsy with brain scan findings group):

  • You are between 18 and 55 years old
  • You have been officially diagnosed with epilepsy according to recognised international criteria
  • Your MRI brain scan shows a specific area that appears to be linked to your seizures, matching your seizure pattern and/or brainwave test results

Who may not be able to join:

Healthy volunteers:

  • You have a current or past neurological condition, serious physical illness, or take medications that could affect test results
  • You are not fluent in Danish, or you have significant vision or hearing difficulties
  • You have a current or past learning disability
  • You are pregnant or breastfeeding (if female)
  • You have been exposed to more than 10 millisieverts (a unit measuring radiation) in research studies in the past year, or you are regularly exposed to radiation through your work
  • You have a reason you cannot have an MRI scan, such as a pacemaker or metal implants
  • You have had a serious head injury
  • You have a current or past problem with alcohol or drug misuse
  • You have used any drugs (other than tobacco or alcohol) in the last 30 days
  • You have used cannabis more than 50 times in your lifetime
  • You have used any individual other substance more than 10 times in your lifetime
  • You are currently taking any medication that affects mood, thinking, or mental health

Patients (all groups, Cohorts I–III):

  • Your life expectancy is less than 10 years
  • You have a known genetic syndrome, significant intellectual disability, or a condition that has caused major changes to your brain structure, such as a brain tumour, major stroke, or serious brain injury
  • You weigh less than 40 kg (approximately 88 lbs)
  • Your kidneys are not working well enough (confirm with trial site for specific kidney function levels)
  • Your liver function is moderately reduced
  • You have a heart rhythm or electrical condition, such as Brugada syndrome or long QT syndrome
  • You take certain medications that could interfere with the study drugs or the study itself — including some seizure medicines, certain antidepressants, or other specific drugs (confirm with trial site for the full list)
  • You have a reason you cannot have an MRI scan, such as a pacemaker or magnetic implants
  • You are unable to complete an MRI scan or, if in Cohort III, a PET scan — for example, due to claustrophobia or severe back pain
  • You have been exposed to more than 10 millisieverts of radiation in research studies in the past year, or are regularly exposed to radiation through work (Cohort III only)
  • You are pregnant or breastfeeding
  • You are not fluent in Danish, or you have significant vision or hearing difficulties, or a severe intellectual disability
  • You have a current or past problem with alcohol or drug misuse

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Lars Hageman Pinborg, MD, Neurobiological Research Unit

Phone: +45 35 45 36 43

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Gitte Moos Knudsen
Registry
ClinicalTrials.gov
Start date
18 February 2022
Est. completion
31 December 2026

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

Categorical effect of anti-seizure medication (ASM) on treatment outcome (Cohort II-III).; Categorical effect of a second seizure/epilepsy diagnosis for patients in Cohort I.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov