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New combo therapy hopes to slow ALS progression

NCT ID NCT07414212

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether taking N-acetylcysteine (NAC) and EH-301 together with the standard drug riluzole can slow down amyotrophic lateral sclerosis (ALS). About 90 people with early-stage ALS will receive either the active combination or a placebo for 6 months. After that, everyone can receive the active treatment for another 6 months. The main goal is to see if the combination helps maintain daily function.

What this could mean

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

Active substance
N-acetylcysteine (NAC) and EH-301 (nicotinamide riboside and pterostilbene) taken together with riluzole
What this could lead to
If it works, this combination could slow down ALS progression and help maintain daily function for longer.
What could go wrong
This is an early-phase trial with only 90 participants, so results may not apply to all ALS patients. The treatment may not slow the disease 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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 90 people

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

Started

Nov 2025

Expected to finish

Nov 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 to 75 years

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. Patients diagnosed with ALS according to the Gold Coast criteria; 2. Disease duration ≤ 18 months; 3. Men and women aged 18 to 75 years; 4. Total ALSFRS-R score ≥ 30 for all 12 categories; 5. Forced vital capacity (FVC) ≥70%; 6. The participant must receive treatment with Riluzole (50 mg twice daily) for ≥30 days prior to Day 1 (Visit 2) and is expected to remain on that dose until the final study visit. 7. Willingness and ability of the patient to comply with the requirements of the protocol during the study; 8. Sign written informed consent prior to any study-related procedure; 9. Acceptance by women to use at least one highly effective method of contraception during the study 30 days prior to taking the nutraceutical and investigational drug and throughout the study. The following are considered highly effective contraceptive methods: * Combined hormonal methods (oral, patches, injectables, or implants). * Hormonal or copper intrauterine devices (IUDs). * Previous surgical sterilization (bilateral tubal ligation). * Total sexual abstinence when consistent with the patient's usual lifestyle. 10. Acceptance by men included in the study of the use of condoms in combination with an effective contraceptive method used by their female partner of childbearing age during treatment. Exclusion Criteria: 1. Presence of other neurodegenerative diseases; 2. Significant cognitive impairment and/or dementia; 3. Any psychiatric illness that could interfere with the study; 4. Use of dietary supplements with high doses of vitamin B3 in the 30 days prior to inclusion in the study; 5. Severe heart disease; 6. Moderate to severe lung disease, such as emphysema, stage III-IV COPD; 7. Uncontrolled chronic asthma; 8. Active cancer; 9. Any metabolic, neoplastic, physically or mentally debilitating disease that could put the subject at risk or interfere with the study results; 10. Genetically confirmed mitochondrial disease; 11. Tracheostomized and/or gastrostomized patients; 12. Participation in any clinical trial with an investigational product within 30 days or five half-lives of the previous agent, whichever is longer, prior to dosing; 13. Any clinically significant laboratory abnormality that could directly affect compliance or safety; 14. Allergy to NAC or any excipient, either in the investigational drug or in the EH301 nutraceutical; 15. Patients with a short life expectancy in the investigator's judgment. 16. \[Women only\] Pregnancy or breastfeeding for women of childbearing potential (i.e., \<2 years postmenopausal or not surgically sterile); 17. The participant is unwilling to use highly effective contraception during the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Hospital Universitario Donostia

    RECRUITING

    San Sebastián, Guipuzcoa, 20003, Spain

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