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

Study Purpose:

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.

Study Status:

Recruiting

Disease:

Amyotrophic Lateral Sclerosis

Study Type:

Interventional

Type of Intervention:

Dietary Supplement

Intervention Name:

EH301 (Nicotinamide Riboside/Pterostilbene)

Placebo:

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

Ole-Bjørn Tysnes, Haukeland University Hospital

Clinicaltrials.gov ID:

NCT04562831

Neals Affiliated?

No

Coordinating Center Contact Information

Study Sponsor:

Haukeland University Hospital

Estimated Enrollment:

380

Estimated Study Start Date:

10 / 07 / 2020

Estimated Study Completion Date:

10 / 01 / 2022

Posting Last Modified Date:

03 / 22 / 2022

Date Study Added to neals.org:

09 / 24 / 2020