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

NCT ID: NCT04562831

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-07
• Study Completion Date: 2026-10-31

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Newly diagnosed ALS patients

1. High dose EH301 (1500mg Nicotinamide riboside / 300mg Pterostilbene)

2. Single dose EH301 (1000mg Nicotinamide riboside / 200mg Pterostilbene)

3. Placebo

Group Type: EXPERIMENTAL

EH301 (Nicotinamide Riboside/Pterostilbene)

Intervention Type: DIETARY_SUPPLEMENT

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

Earlier diagnosed ALS patients

1. High dose EH301 (1500mg Nicotinamide riboside / 300mg Pterostilbene)

2. Placebo

Group Type: EXPERIMENTAL

EH301 (Nicotinamide Riboside/Pterostilbene)

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elysium Health

INDUSTRY

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ole-Bjørn Tysnes

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

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

Countries

Norway

Other Identifiers

98955

Identifier Type: -

Identifier Source: org_study_id