Epilepsy Trial, Recruiting NCT06608966 Sponsor: Children's Hospital Medical Center, Cincinnati Condition: Epilepsy
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Epilepsy Trial, Recruiting

NCT06608966
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:

  • The young person must be between 13 and 17 years old at the time of joining.
  • The young person must live at home with their main caregiver and be enrolled in school (not counting summer breaks).
  • The young person must have a confirmed epilepsy diagnosis, with seizures that have a clear starting point — either affecting the whole brain at once or starting in one area of the brain.
  • The young person's primary language must be English.
  • Based on a parent-completed questionnaire about thinking and planning skills (called the BRIEF-2), the young person must show certain levels of difficulty with these skills — specifically, scoring in a subclinical or clinical range on at least some sections of the questionnaire.
  • A parent or legal guardian must be willing to sign an official consent form approved by an ethics review board.
  • The young person must be willing to sign their own agreement form to take part, also approved by an ethics review board.

Who may not be able to join:

  • Young people with a reported history of developmental delay, such as autism spectrum disorder, intellectual disability, or a known IQ below 70.
  • Young people with a history of serious mental illness, such as schizophrenia, bipolar disorder, an eating disorder in the past 12 months, or depression with thoughts of suicide in the past 3 months.
  • Young people with a current or recent history (within the past 3 months) of trauma-related conditions, such as post-traumatic stress disorder (PTSD).
  • Young people with a recent or ongoing significant medical condition affecting the heart, liver, kidneys, hormones, muscles, or metabolism.
  • Young people with a history of brain injury or brain tumour.
  • Young people who have had epilepsy surgery.
  • Young people with any other medical or mental health condition that would need to be treated before this study's program.
  • Young people whose seizure type cannot be clearly classified due to insufficient information about how the seizures begin.
  • Young people whose epilepsy is currently being managed with three or more anti-seizure medications at the time of joining (not counting emergency rescue medications).
  • Young people whose epilepsy has not responded to four or more different anti-seizure medications tried in the past.
  • Young people with a confirmed or suspected epileptic encephalopathy (a type of serious brain condition linked to epilepsy) (confirm with trial site).
  • Young people with a confirmed or suspected condition that is progressive or degenerative, such as certain metabolic, mitochondrial, or autoimmune disorders.
  • Young people who have had a prolonged seizure episode (status epilepticus) within the 24 weeks before joining.
  • Young people whose seizures are caused by a treatable underlying cause, such as a metabolic problem, tumour, or active infection.
  • Young people whose episodes have been identified as non-epileptic seizures (events that look like seizures but are not caused by epilepsy).
  • Young people currently following a ketogenic diet.
  • Young people who have taken part in a trial of an experimental drug or medical device within the 30 days before screening.

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 21 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: Avani Modi, Ph.D., Children's Hospital Medical Center, Cincinnati

Phone: 513-636-4864

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
Registry
ClinicalTrials.gov
Start date
11 November 2024
Est. completion
31 October 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Behavior Rating Inventory of Executive Function (2nd edition) Global Executive Composite T-score (parent)

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: 21 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