NCT05095571

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

Recruiting now NA Last updated 19 March 2025

What this trial tests

NA trial testing EH301 (Nicotinamide Riboside/Pterostilbene) in Amyotrophic Lateral Sclerosis in 300 participants. Currently enrolling.

Timeline

7 October 2021

Primary endpoint
31 December 2025

31 December 2026

Quick facts

Lead sponsor	Haukeland University Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	7 October 2021
Primary completion	31 December 2025
Estimated completion	31 December 2026
Sites	17 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 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.

Publications & conference data

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

1. New Insights into Dietary Pterostilbene: Sources, Metabolism, and Health Promotion Effects.
   Nagarajan S, Mohandas S, Ganesan K, Xu B, et al · · 2022 · cited 57× · PMID 36234852 · DOI 10.3390/molecules27196316
2. 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
3. Molecular mechanisms and therapeutic strategies for neuromuscular diseases.
   Zambon AA, Falzone YM, Bolino A, Previtali SC. · · 2024 · cited 7× · PMID 38678519 · DOI 10.1007/s00018-024-05229-9
4. 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
5. Advances in antitumor effects of pterostilbene and its derivatives.
   Yu X, Xu M, Gao Z, Guan H, et al · · 2025 · cited 3× · PMID 39655793 · DOI 10.1080/17568919.2024.2435251
6. Drug repurposing candidates for amyotrophic lateral sclerosis using common and rare genetic variants.
   Gerring ZF, Bhalala OG, Fearnley LG, Oikari LE, et al · · 2025 · cited 2× · PMID 40395632 · DOI 10.1093/braincomms/fcaf184