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Could vitamin B3 save sight in rare genetic blindness?

NCT ID NCT07258667

Disease control 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests whether high-dose vitamin B3 (nicotinamide) can help preserve or improve vision in people with Leber's hereditary optic neuropathy (LHON), a rare genetic disease that causes sudden vision loss. Researchers will give 13 participants 2 grams of vitamin B3 daily for 12 months and track changes in eyesight. The goal is to see if this simple supplement can support eye cell health and slow vision decline.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 13 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

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.

Ages

16 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: * Patients aged 16 years or older. * Diagnosis of Leber Hereditary Optic Neuropathy (LHON) due to a confirmed mitochondrial DNA mutation m.11778G\>A or m.3460G\>A. * Onset of LHON symptoms less than 18 months before inclusion. * Naïve to nicotinamide treatment for at least 3 months prior to inclusion. * Able to take oral medication and comply with study procedures. * Affiliated with or beneficiary of a social security system. * Signed informed consent (or parental consent for minors; assent for minors when applicable). Exclusion Criteria: * Asymptomatic carriers of m.11778G\>A or m.3460G\>A mutations (no clinical LHON). * LHON due to other mitochondrial DNA mutations or nuclear DNA mutations. * LHON onset more than 18 months before inclusion. * Current or recent treatment with idebenone (within 3 months). * Severe associated ophthalmologic disease (e.g., advanced glaucoma, retinal pathology). * Patients treated with gene therapy. * Elevated liver enzymes (ASAT and/or ALAT \> 2× upper normal limit) at screening or within 2 months prior to inclusion. * Pregnant, breastfeeding, or postpartum women. * Known contraindication to nicotinamide or allergy/intolerance to lactose or galactose. * Persons deprived of liberty by judicial or administrative decision. * Subjects under legal protection or psychiatric care under constraint. * Unable to provide informed consent. * Participation in another interventional study affecting LHON management. * Any condition that, in the investigator's judgment, could compromise patient safety or study integrity.

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Conditions

The condition(s) this trial relates to.

inborn mitochondrial metabolism disorder Leber hereditary optic neuropathy mitochondrial disease optic nerve disorder

As listed by the trial registrant

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

Leber hereditary optic neuropathy (LHON) Leber's hereditary optic neuropathy (LHON) Mitochondrial disease Optic nerve disease

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

  • Angers University Hospital

    Angers, 49933, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.