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Can a simple supplement slow ALS? new study investigates

NCT ID NCT04562831

Disease control Sponsor: Haukeland University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a combination of nicotinamide (a form of vitamin B3) and pterostilbene (a plant compound) can slow the progression of ALS, a fast-moving nerve disease. About 380 adults with ALS will take either the supplement or a placebo for a period of time. The goal is to see if the treatment helps maintain muscle function and improve survival and quality of life.

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

About 380 people

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

Started

Oct 2020

Expected to finish

Oct 2026

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

35 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: Arm 1 (newly diagnosed ALS patients) * Have a clinical diagnosis of probable ALS according to the revised El Escorial criteria. * MR of the brain and cervical spine cannot explain symptoms. * Diagnosed with likely ALS within 6 months from enrolment and treated with Riluzole 50mg x 2 * Symptom onset no longer than 2 year prior to inclusion. * ALS-FRC-R of 36 or more (not any item below 2). * Age equal to or greater than 35 years at time of enrollment Arm 2 (earlier diagnosed ALS patients) * Have a clinical diagnosis of probable ALS according to the revised El Escorial criteria. * MR of the brain and cervical spine cannot explain symptoms. * Treated with Riluzole 50mg x 2. Exclusion Criteria: * Dementia, FTD or other neurodegenerative disorder at baseline visit * Any psychiatric disorder that would interfere with compliance in the study. * Use of high dose vitamin B3 supplementation within 30 days of enrollment * Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit. * Genetically confirmed mitochondrial disease * Patients who become tracheostomized as part of the treatment of ALS * Patients with short expected survival at the discretion of the investigator. Such cases cannot be expected to follow protocol procedures.

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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

Contacts and locations

Locations

  • Akershus University Hospital

    Lørenskog, Norway

  • Haukeland University Hospital

    Bergen, Norway

  • Helse Fonna HF

    Haugesund, Norway

  • Helse Førde HF

    Førde, Norway

  • Oslo University Hospital

    Oslo, Norway

  • St.Olavs Hospital HF

    Trondheim, Norway

  • Stavanger University Hospital

    Stavanger, Norway

  • Universitetssykehuset Nord-Norge

    Tromsø, Norway

  • Vestre Viken HF

    Drammen, Norway

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