New combo therapy hopes to slow ALS progression
NCT ID NCT07414212
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Hospital Universitario Donostia
RECRUITINGSan Sebastián, Guipuzcoa, 20003, Spain
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