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Can a High-Fat diet and therapy tame seizures in rare childhood epilepsy?

NCT ID NCT07745608

Disease control Sponsor: Uskudar University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study asks whether adding a medically supervised ketogenic diet to occupational therapy can help children aged 4 to 7 with ARX gene mutations and drug-resistant epilepsy. Twenty children will take part: half follow the ketogenic diet while the other half do not, and both groups receive occupational therapy for 16 weeks. Researchers will track seizure frequency, motor skills, balance, sensory processing, chewing, eating behaviors, and quality of life to see if the diet makes a meaningful difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Medical ketogenic diet therapy combined with individualized occupational therapy
What this could lead to
If effective, this combination could offer a non-drug way to reduce seizures and improve motor and daily living skills in children with ARX-related epilepsy.
What could go wrong
The trial is small (20 children) and early, so results may not apply broadly. The ketogenic diet can be hard to follow and may have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Feb 2026

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 7 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age between 4 and 7 years. * Genetically confirmed ARX gene mutation. * Diagnosis of drug-resistant epilepsy. * For the experimental group, initiation of or planned initiation of classical ketogenic diet therapy as part of routine clinical care. * For the control group, continuation of standard neurological treatment and usual diet without ketogenic diet therapy. * Eligibility for the target age ranges of the assessment tools used in the study. * Written informed consent provided by a parent or legal caregiver. Exclusion Criteria: * Presence of an additional neurological or genetic disorder, other than ARX mutation and epilepsy, that could affect ketogenic diet implementation or assessment outcomes. * Presence of a severe orthopedic or systemic medical condition that could prevent completion of follow-up and assessments. * Severe communicative or cognitive limitations that could prevent valid and reliable administration of the assessment tools.

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Conditions

The condition(s) this trial relates to.

developmental and epileptic encephalopathy, 1 Drug Resistant Epilepsy Feeding Behavior

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arx gene mutation Arx-related epilepsy Drug resistant epilepsy

Contacts and locations

Locations

  • Ilk Evre Special Education and Rehabilitation Center

    Istanbul, Istanbul, 34418, Turkey (Türkiye)

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