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Can a special diet shape brain development in a rare epilepsy?

NCT ID NCT06054347

Knowledge-focused Sponsor: University Hospital, Angers 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This study looks at how children over age 3 with pyridoxine-dependent epilepsy, a rare genetic condition, develop cognitively over time. Researchers will use a standardized questionnaire called Vineland II to measure adaptive behaviors like communication and daily living skills. The goal is to see if current treatments, especially a lysine-restricted diet, influence long-term neurocognitive outcomes.

What this could mean

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

Active substance
Vineland II Adaptive Behaviour Scales questionnaire
What this could lead to
If successful, this could clarify how treatments like a lysine-restricted diet affect long-term brain development in children with this rare epilepsy.
What could go wrong
This is a small observational study, so results may not apply to all patients. It measures development at one point, not long-term change.

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.

Participants

30 people

The number who actually took part.

Started

Dec 2023

Finished

May 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Who is studied

Cohort of patients diagnosed with pyridoxine dependent epilepsy and already published (Gibaud et al) completed with new cases.

Ages

3 years and older

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 above 3 years old * Pyridoxine dependent epilepsy genetic diagnosis (mutation in ALDH7A1 gene) * No objection of the patient or his legal representatives. Exclusion Criteria: * Poor understanding of French language.

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Conditions

The condition(s) this trial relates to.

pyridoxine-dependent epilepsy

As listed by the trial registrant

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

Pyridoxine-dependent epilepsy

Contacts and locations

Locations

  • CHRU Morvan

    Brest, 29609, France

  • CHU Angers

    Angers, 49100, France

  • CHU Gui de Chautiac

    Montpellier, 34295, France

  • CHU Toulouse

    Toulouse, 31100, France

  • CHU d'Estaing

    Clermont-Ferrand, 63003, France

  • Centre Hospitalier Saint Nazaire

    Saint-Nazaire, 44600, France

  • Centre Hospitalier Universitaire de Besançon

    Besançon, 25030, France

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • Hôpital Clocheville

    Tours, 37000, France

  • Hôpital Jeanne de Flandre

    Lille, 59037, France

  • Hôpital Necker-Enfants malades

    Paris, 75749, France

  • Hôpital de la Timone-Enfants

    Marseille, 13005, France

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