NCT05095571Active, not recruiting
A Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Extension Study
A Randomized Placebo-controlled Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Study. Extension Protocol
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The mean survival from the time of diagnosis is 2.5 years. Apart from Riluzole, there is no effective treatment. Care of advanced ALS will have a cost of 4-8 million NOK (Norwegian kroner) per year. Research i.a. from the investigators department has shown that increased activity in histone deacetylation enzymes (sirtuins) together with increased access to Nicotinamide Adenine Dinucleotide (NAD) can delay disease progression. Nicotinamide riboside (NR) can increase cells' access to NAD and Pterostilbene will stimulate sirtuins. The investigators want to study whether combination therapy with NR and Pterostilbene can inhibit neurodegeneration in ALS and thereby delay disease development, increase survival and improve quality of life in ALS. In the NO-ALS extension study the investigators will follow the patients who completed the original NO-ALS study. Objectives are to evaluate adverse events and give patients possibility of compassionate use, and secondarily to see if the combination of NR and pterostilbene (EH301) will decrease progression of motor symptoms and loss of vital capacity, and increase survival time in patients with ALS.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 4 Oct 2021
- Start date
- 7 Oct 2021
- Primary completion date
- 15 Oct 2026
- Lead sponsor
- Haukeland University Hospital
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT05095571
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 7 Oct 2021 to the primary completion date, 15 Oct 2026
- 17 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, fronto temporal dementia (FTD) or other neurodegenerative disorder interfering with compliance.
- Metabolic, neoplastic, or other physically or mentally debilitating disorder.
Other
- Individuals will be excluded if any of the following exclusion criteria apply:
- 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.
- Use of Vit B3 or blue berry extracts outside the study
Who the study is looking for
- Patients who fulfilled the criteria for the NO-ALS study and have completed the study will be proposed inclusion in the NO-ALS extension study protocol. Patients from both arm 1 and arm 2 in the NO-ALS study will be allowed inclusion in the prolongation study
Age in the registry: 35 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
| Nordlandssykehuset HF Coordinator of this site? Confirm its status | Bodø | 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 |
| Sørlandet Sykehus Coordinator of this site? Confirm its status | Kristiansand | Norway | Unknown status |
| Sykehuset Innlandet HF Coordinator of this site? Confirm its status | Lillehammer | Norway | Unknown status |
| Akershus University Hospital Coordinator of this site? Confirm its status | Lørenskog | Norway | Unknown status |
| Helse Møre og Romsdal Coordinator of this site? Confirm its status | Molde | Norway | Unknown status |
| Helse Nord-Trøndelag HF Coordinator of this site? Confirm its status | Namsos | Norway | Unknown status |
| Oslo Univerity Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Sykehuset Østfold HF Coordinator of this site? Confirm its status | Sarpsborg | Norway | Unknown status |
| Sykehuset i Telemark HF Coordinator of this site? Confirm its status | Skien | Norway | Unknown status |
| Stavanger University Hospital Coordinator of this site? Confirm its status | Stavanger | Norway | Unknown status |
| Sykehuset i Vestfold HF Coordinator of this site? Confirm its status | Tønsberg | 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.