NCT04562831

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

Active, enrolled NA Last updated 12 January 2026

What this trial tests

NA trial testing EH301 (Nicotinamide Riboside/Pterostilbene) in Amyotrophic Lateral Sclerosis in 380 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

7 October 2020

Primary endpoint
31 October 2026

31 October 2026

Quick facts

Lead sponsor	Haukeland University Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	380
Start date	7 October 2020
Primary completion	31 October 2026
Estimated completion	31 October 2026
Sites	9 locations across Norway

Drugs / interventions tested

• EH301 (Nicotinamide Riboside/Pterostilbene)

Conditions studied

• Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →

Sponsor

Haukeland University Hospital

Who can join

35 and older, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Link between Oxidative Stress, Redox Status, Bioenergetics and Mitochondria in the Pathophysiology of ALS.
   Obrador E, Salvador-Palmer R, López-Blanch R, Jihad-Jebbar A, et al · · 2021 · cited 69× · PMID 34198557 · DOI 10.3390/ijms22126352
2. A Gut Feeling in Amyotrophic Lateral Sclerosis: Microbiome of Mice and Men.
   Martin S, Battistini C, Sun J. · · 2022 · cited 40× · PMID 35360111 · DOI 10.3389/fcimb.2022.839526
3. Roles of NAD<sup>+</sup> in Health and Aging.
   Lautrup S, Hou Y, Fang EF, Bohr VA. · · 2024 · cited 28× · PMID 37848251 · DOI 10.1101/cshperspect.a041193
4. NAD⁺ Metabolism and Diseases with Motor Dysfunction.
   Lundt S, Ding S. · · 2021 · cited 20× · PMID 34828382 · DOI 10.3390/genes12111776
5. NAD⁺ Precursors and Antioxidants for the Treatment of Amyotrophic Lateral Sclerosis.
   Obrador E, Salvador-Palmer R, López-Blanch R, Dellinger RW, et al · · 2021 · cited 14× · PMID 34440204 · DOI 10.3390/biomedicines9081000
6. Stilbenes: a promising small molecule modulator for epigenetic regulation in human diseases.
   Tian J, Jin L, Liu H, Hua Z. · · 2023 · cited 12× · PMID 38155902 · DOI 10.3389/fphar.2023.1326682
7. Nicotinamide Adenine Dinucleotide (NAD⁺)-Dependent Signaling in Neurological Disorders.
   Bresque M, Esteve D, Pehar M, Vargas MR. · · 2023 · cited 10× · PMID 37288742 · DOI 10.1089/ars.2023.0241
8. Nicotinamide riboside, pterostilbene and ibudilast protect motor neurons and extend survival in ALS mice.
   López-Blanch R, Salvador-Palmer R, Oriol-Caballo M, Moreno-Murciano P, et al · · 2024 · cited 4× · PMID 38241160 · DOI 10.1016/j.neurot.2023.10.011