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

Last updated: March 17, 2025
Sponsor: Haukeland University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myasthenia Gravis (Chronic Weakness)

Amyotrophic Lateral Sclerosis (Als)

Treatment

EH301 (Nicotinamide Riboside/Pterostilbene)

Clinical Study ID

NCT05095571
266376
  • Ages > 35
  • All Genders

Study Summary

Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The mean survival from the time of diagnosis is 2.5 years. Apart from Riluzole, there is no effective treatment. Care of advanced ALS will have a cost of 4-8 million NOK (Norwegian kroner) per year.

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

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

In the NO-ALS extension study the investigators will follow the patients who completed the original NO-ALS study. Objectives are to evaluate adverse events and give patients possibility of compassionate use, and secondarily to see if the combination of NR and pterostilbene (EH301) will decrease progression of motor symptoms and loss of vital capacity, and increase survival time in patients with ALS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who fulfilled the criteria for the NO-ALS study and have completed thestudy will be proposed inclusion in the NO-ALS extension study protocol. Patientsfrom both arm 1 and arm 2 in the NO-ALS study will be allowed inclusion in theprolongation study

Exclusion

Exclusion Criteria:

Individuals will be excluded if any of the following exclusion criteria apply:

  • Dementia, fronto temporal dementia (FTD) or other neurodegenerative disorderinterfering with compliance.

  • Metabolic, neoplastic, or other physically or mentally debilitating disorder.

  • 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.

  • Use of Vit B3 or blue berry extracts outside the study

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: EH301 (Nicotinamide Riboside/Pterostilbene)
Phase:
Study Start date:
October 07, 2021
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Haukeland University Hospital

    Bergen,
    Norway

    Active - Recruiting

  • Nordlandssykehuset HF

    Bodø,
    Norway

    Site Not Available

  • Vestre Viken HF

    Drammen,
    Norway

    Site Not Available

  • Helse Førde HF

    Førde,
    Norway

    Site Not Available

  • Helse Fonna HF

    Haugesund,
    Norway

    Site Not Available

  • Sørlandet sykehus

    Kristiansand,
    Norway

    Site Not Available

  • Sykehuset Innlandet HF

    Lillehammer,
    Norway

    Site Not Available

  • Akershus University Hospital

    Lørenskog,
    Norway

    Site Not Available

  • Helse Møre og Romsdal

    Molde,
    Norway

    Site Not Available

  • Helse Nord-Trøndelag HF

    Namsos,
    Norway

    Site Not Available

  • Oslo Univerity Hospital

    Oslo,
    Norway

    Site Not Available

  • Sykehuset Østfold HF

    Sarpsborg,
    Norway

    Site Not Available

  • Sykehuset i Telemark HF

    Skien,
    Norway

    Site Not Available

  • Stavanger University Hospital

    Stavanger,
    Norway

    Site Not Available

  • Universitetssykehuset Nord-Norge

    Tromsø,
    Norway

    Site Not Available

  • St. Olavs Hospital HF

    Trondheim,
    Norway

    Site Not Available

  • Sykehuset i Vestfold HF

    Tønsberg,
    Norway

    Site Not Available

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