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:



Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:

Dietary Supplement

Intervention Name:

EH301 (Nicotinamide Riboside/Pterostilbene)




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

Ole-Bjørn Tysnes, Haukeland University Hospital

Clinicaltrials.gov ID:


Neals Affiliated?


Coordinating Center Contact Information

Ole-Bjørn Tysnes / email hidden; JavaScript is required / +4755975063

Study Sponsor:

Haukeland University Hospital

Estimated Enrollment:


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

Minimum Age:

35 Years

Maximum Age:


Inclusion Criteria:

Arm 1 (newly diagnosed ALS patients)

- Have a clinical diagnosis of probable ALS according to the revised El Escorial criteria.

- MR of the brain and cervical spine cannot explain symptoms.

- Diagnosed with likely ALS within 6 months from enrolment and treated with Riluzole 50mg x 2

- Symptom onset no longer than 2 year prior to inclusion.

- ALS-FRC-R of 36 or more (not any item below 2).

- Age equal to or greater than 35 years at time of enrollment

Arm 2 (earlier diagnosed ALS patients)

- Have a clinical diagnosis of probable ALS according to the revised El Escorial criteria.

- MR of the brain and cervical spine cannot explain symptoms.

- Treated with Riluzole 50mg x 2.

Exclusion Criteria:

- Dementia, FTD or other neurodegenerative disorder at baseline visit

- Any psychiatric disorder that would interfere with compliance in the study.

- Use of high dose vitamin B3 supplementation within 30 days of enrollment

- Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.

- Genetically confirmed mitochondrial disease

- Patients who become tracheostomized as part of the treatment of ALS

- Patients with short expected survival at the discretion of the investigator. Such cases cannot be expected to follow protocol procedures.

Haukeland University Hospital | Recruiting

Ole-Bjørn Tysnes

Principal Investigator : Ole-Bjørn Tysnes


Vestre Viken HF | Recruiting

Ingrid Kristine Bjørnå

Principal Investigator : Ingrid Kristine Bjørnå


Helse Førde HF | Recruiting

Kristin Lif Breivik

Principal Investigator : Kristin Lif Breivik


Helse Fonna HF | Recruiting

Ineke HogenEsch

Principal Investigator : Ineke HogenEsch


Akershus University Hospital | Recruiting

Ola Nakken

Principal Investigator : Ola Nakken


Oslo University Hospital | Recruiting

Angelina Maniaol

Principal Investigator : Angelina Maniaol


Stavanger University Hospital | Recruiting

Katrin Ruth Schlüter

Principal Investigator : Katrin Ruth Schlüter


Universitetssykehuset Nord-Norge | Recruiting

Margitta Kampmann

Principal Investigator : Margitta Kampmann


St.Olavs Hospital HF | Recruiting

Sigrid Botne Sando

Principal Investigator : Sigrid Botne Sando