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ACTIVE NOT RECRUITING
NCT04562831
NA

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

Sponsor: Haukeland University Hospital

View on ClinicalTrials.gov

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.

Official title: A Randomized Placebo-controlled Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Study

Key Details

Gender

All

Age Range

35 Years - Any

Study Type

INTERVENTIONAL

Enrollment

380

Start Date

2020-10-07

Completion Date

2026-10-31

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

EH301 (Nicotinamide Riboside/Pterostilbene)

Comparison of 2 different dosages with placebo in newly diagnosed ALS patients and comparison of high dose with placebo in earlier ALS patients.

Locations (9)

Haukeland University Hospital

Bergen, Norway

Vestre Viken HF

Drammen, Norway

Helse Førde HF

Førde, Norway

Helse Fonna HF

Haugesund, Norway

Akershus University Hospital

Lørenskog, Norway

Oslo University Hospital

Oslo, Norway

Stavanger University Hospital

Stavanger, Norway

Universitetssykehuset Nord-Norge

Tromsø, Norway

St.Olavs Hospital HF

Trondheim, Norway