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Sugar supplement may calm seizures and stomach troubles in rare genetic disease

NCT ID NCT05402384

Disease control Sponsor: Eva Morava-Kozicz 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study tests whether a sugar called D-galactose (AVTX-801) can help people with SLC35A2-CDG, a rare inherited disorder that disrupts how the body adds sugar to proteins. The trial enrolls about 10 people of any age who have seizures or chronic digestive issues. Participants receive either D-galactose or a placebo in a crossover design, so everyone gets both over time. The goal is to see if the supplement reduces seizure frequency and improves stool consistency.

What this could mean

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

Active substance
D-galactose (AVTX-801)
What this could lead to
If it works, this could point toward a treatment that reduces seizures and digestive problems in people with SLC35A2-CDG.
What could go wrong
This is a small, early-phase trial with only 10 participants, so results may not apply to everyone. The supplement may not improve symptoms or could cause 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

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

1 month 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 * Molecular confirmation of SLC35A2 genetic variant * Age \> 1 month * Presence of seizures, chronic vomiting, chronic constipation, or chronic diarrhea * A parent or legal guardian must be available and willing to provide consent on behalf of minor subjects or adult subjects who are unable to give informed consent due to developmental disabilities. * Use of contraception in females \> age 8 years * Previously performed eye exam within last year Exclusion Criteria * Aldolase-B deficiency * Galactosemia * Hemolytic uremic syndrome * Hemoglobin \< 7 mg/dL * LFTs \> 3x ULN * Previously experienced severe AEs from oral galactose (severe diarrhea, vomiting, constipation, galactosuria, or increased liver glycogen storage) * Other history of galactose intolerance as determined by the investigator * Currently treated with ketogenic diet * Current enrollment in another trial involving investigational compounds * Ongoing dietary D-galactose supplementation * Use of investigational compounds * Pregnancy

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Conditions

The condition(s) this trial relates to.

SLC35A2-congenital disorder of glycosylation

As listed by the trial registrant

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

SLC35A2-CDG - solute carrier family 35 member A2 congenital disorder of glycosylation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic Minnesota

    Rochester, Minnesota, 55905, United States