The NO-ALS Study: A Trial of Nicotinamide/Pterostilbene Supplement in ALS.

Last updated: January 9, 2026
Sponsor: Haukeland University Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Amyotrophic Lateral Sclerosis (Als)

Myasthenia Gravis (Chronic Weakness)

Treatment

EH301 (Nicotinamide Riboside/Pterostilbene)

Clinical Study ID

NCT04562831
98955
  • Ages > 35
  • All Genders

Study Summary

Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The average survival from the time of diagnosis is 3 years. Apart from Riluzole, there is no effective treatment. Care of advanced ALS will have a cost of 4-8 million NOK per year

Research i.a. from the investigators department has shown that increased activity in histone deacetylation enzymes (sirtuins) together with increased access to NAD can delay disease progression. Nicotinamide riboside (NR) can increase cells' access to NAD and Pterostilben will stimulate sirtuins.

The investigators want to study whether combination therapy with NR and Pterostilben can inhibit neurodegeneration in ALS and thereby delay disease development, increase survival and improve quality of life in ALS.

In the study, the investigators will use 2 different dosages on the active treatment and strength calculations show that 180 patients are needed to show a rather weak effect. Patients will be recruited in collaboration with hospitals in Helse Vest, AHUS, Drammen, OUS and St. Olavs hospital.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Arm 1 (newly diagnosed ALS patients)

  • Have a clinical diagnosis of probable ALS according to the revised El Escorialcriteria.

  • 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 Escorialcriteria.

  • MR of the brain and cervical spine cannot explain symptoms.

  • Treated with Riluzole 50mg x 2.

Exclusion

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 atbaseline 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. Suchcases cannot be expected to follow protocol procedures.

Study Design

Total Participants: 380
Treatment Group(s): 1
Primary Treatment: EH301 (Nicotinamide Riboside/Pterostilbene)
Phase:
Study Start date:
October 07, 2020
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Haukeland University Hospital

    Bergen,
    Norway

    Site Not Available

  • Haukeland University Hospital

    Bergen 3161732,
    Norway

    Site Not Available

  • Vestre Viken HF

    Drammen,
    Norway

    Site Not Available

  • Vestre Viken HF

    Drammen 3159016,
    Norway

    Site Not Available

  • Helse Førde HF

    Førde,
    Norway

    Site Not Available

  • Helse Førde HF

    Førde 3156804,
    Norway

    Site Not Available

  • Helse Fonna HF

    Haugesund,
    Norway

    Site Not Available

  • Helse Fonna HF

    Haugesund 3153623,
    Norway

    Site Not Available

  • Akershus University Hospital

    Lørenskog,
    Norway

    Site Not Available

  • Oslo University Hospital

    Oslo,
    Norway

    Site Not Available

  • Oslo University Hospital

    Oslo 3143244,
    Norway

    Site Not Available

  • Stavanger University Hospital

    Stavanger,
    Norway

    Site Not Available

  • Stavanger University Hospital

    Stavanger 3137115,
    Norway

    Site Not Available

  • Universitetssykehuset Nord-Norge

    Tromsø,
    Norway

    Site Not Available

  • Universitetssykehuset Nord-Norge

    Tromsø 3133895,
    Norway

    Site Not Available

  • St.Olavs Hospital HF

    Trondheim,
    Norway

    Site Not Available

  • St.Olavs Hospital HF

    Trondheim 3133880,
    Norway

    Site Not Available

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