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Can a common supplement help ALS patients stay independent longer?

NCT ID NCT06126315

Disease control Sponsor: Mario Negri Institute for Pharmacological Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether acetyl-L-carnitine (ALCAR), a natural supplement, can slow the loss of self-sufficiency in people with ALS. About 246 adults with early-stage ALS will receive either a low or high dose of ALCAR or a placebo for 48 weeks, alongside standard care. Researchers will track changes in muscle function, breathing, quality of life, and survival to see if ALCAR offers any benefit.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 246 people

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

Started

Mar 2025

Expected to finish

Sep 2027

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

18 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: 1. Age 18+; 2. ALS diagnosis according to the Gold Coast Criteria; 3. Disease duration \< 24 months from symptom onset, as indicated by limb weakness or bulbar symptoms, at the randomization/baseline visit\*; 4. Self-sufficiency \[Satisfactory bulbar and spinal function (score 3+ on the ALSFRS-R for swallowing, cutting food and handling utensils, and walking)\]; 5. Satisfactory respiratory function (FVC ≥80% of predicted); 6. Documented progression of symptoms as measured by the ALSFRS-R scale. Disease progression rate (DFS) must be\>= 0.33. DFS =(48- ALSFRS-R at screening)/months from onset to screening. 7. Ability to understand and comply with the study requirements; 8. Ability to give written informed consent personally or, as an alternative, via a legally authorized representative; 9. Treatment with riluzole 50 mg twice/day for at least 4 weeks prior to randomization visit; 10. Intact cognitive function, again determined by the Principal Investigator. * The qualifying first symptoms of ALS are limited to manifestations of weakness in extremity, bulbar, or respiratory muscles. Cramps, fasciculations, or fatigue should not be taken in isolation as a first symptom of ALS. Exclusion Criteria: 1. Antecedent polio infection or other active infection; 2. Motor neuron disease (MND) other than ALS; 3. Involvement of other systems possibly determining a functional impairment (as measured by the endpoints) for the entire duration of the study; 4. Other severe clinical conditions (e.g., cardiovascular disorders, neoplasms) with an impact on survival or functional disability in the next 12 months; 5. Previous use of ALCAR for any reason; 6. Poor compliance with previous treatments; 7. Other experimental treatments in the three months prior to the screening visit (if a subject is receiving another experimental drug, a 3-month wash-out period before participating in the present clinical trial will be required); 8. Women who are lactating or able to become pregnant (e.g. who are not post-menopausal, surgically sterile, or using inadequate birth control) and men unable to practice contraception for the duration of the treatment and three months after its completion; 9. Inability to understand and comply with the study requirements; 10. Unwillingness or inability to take riluzole.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

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

Amyotrophic lateral sclerosis

How to take part

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

  1. The places running it

    19 sites in 2 countries. 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

  • A.S.P. Palermo, Villa delle Ginestre Hospital

    NOT_YET_RECRUITING

    Palermo, 90135, Italy

  • AOU di Modena Nuovo Ospedale Civile S. Agostino Estense di Modena - Ospedale di Baggiovara

    RECRUITING

    Modena, 41126, Italy

  • Azienda Ospedale-Università di Padova, Unità di Neurologia Clinica

    RECRUITING

    Padova, 35128, Italy

  • Azienda Ospedaliera Universitaria "Luigi Vanvitelli", Dipartimento di Scienze mediche e chirurgiche avanzate

    NOT_YET_RECRUITING

    Naples, 80138, Italy

  • Azienda Ospedaliera Universitaria Federico II Di Napoli

    RECRUITING

    Naples, 80131, Italy

  • Azienda Ospedaliera di Perugia

    NOT_YET_RECRUITING

    Perugia, 06156, Italy

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, 56124, Italy

  • Azienda Ospedaliero Universitaria Pisana, Dipartimento di Medicina Clinica e Sperimentale

    NOT_YET_RECRUITING

    Pisa, Italy

  • Azienda Ospedaliero-Universitaria Maggiore della Carità

    RECRUITING

    Novara, 28100, Italy

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I - Università di Roma "La Sapienza"

    RECRUITING

    Roma, 00161, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Dipartimento di Neurologia

    RECRUITING

    Bergamo, 24127, Italy

  • Concord Hospital

    RECRUITING

    Sydney, 2139, Australia

  • Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

    RECRUITING

    Pavia, 27100, Italy

  • Fondazione Serena ONLUS - Centro Clinico NeMO Ancona

    RECRUITING

    Torrette, 60126, Italy

  • Fondazione Serena ONLUS Centro Clinico NEMO Brescia

    RECRUITING

    Brescia, 25064, Italy

  • Fondazione Serena ONLUS centro clinico NEMO

    RECRUITING

    Milan, 20162, Italy

  • Fondazione Serena ONLUS-Centro Clinico NEMO Trento

    RECRUITING

    Pergine Valsugana, 38057, Italy

  • Istituto Auxologico Italiano, IRCCS Dipartimento di Neurologia

    RECRUITING

    Milan, 20149, Italy

  • San Camillo Forlanini Hospital, Center for Neuromuscolar and Neurological Rare Diseases, Unit of Neurology and Neurophysiopathology

    NOT_YET_RECRUITING

    Roma, 00152, Italy

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