NCT04562831Active, not recruiting
The NO-ALS Study: A Trial of Nicotinamide/Pterostilbene Supplement in ALS.
A Randomized Placebo-controlled Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Study
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 380 (estimated)
- First submitted
- 10 Sept 2020
- Start date
- 7 Oct 2020
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Haukeland University Hospital
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT04562831
What you commit to
- Study type: Interventional
- Planned participants: 380
- From 7 Oct 2020 to the primary completion date, 31 Oct 2026
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Dementia, FTD or other neurodegenerative disorder at baseline visit
- Any psychiatric disorder that would interfere with compliance in the study.
- Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.
- Genetically confirmed mitochondrial disease
Other
- Use of high dose vitamin B3 supplementation within 30 days of enrollment
- 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.
Who the study is looking for
- 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.
Age in the registry: 35 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
| Vestre Viken HF Coordinator of this site? Confirm its status | Drammen | Norway | Unknown status |
| Helse Førde HF Coordinator of this site? Confirm its status | Førde | Norway | Unknown status |
| Helse Fonna HF Coordinator of this site? Confirm its status | Haugesund | Norway | Unknown status |
| Akershus University Hospital Coordinator of this site? Confirm its status | Lørenskog | Norway | Unknown status |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Stavanger University Hospital Coordinator of this site? Confirm its status | Stavanger | Norway | Unknown status |
| Universitetssykehuset Nord-Norge Coordinator of this site? Confirm its status | Tromsø | Norway | Unknown status |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.