Actively Recruiting
A Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Extension Study
Led by Haukeland University Hospital · Updated on 2025-03-19
300
Participants Needed
17
Research Sites
273 weeks
Total Duration
On this page
Sponsors
H
Haukeland University Hospital
Lead Sponsor
E
Elysium Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Extension Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who fulfilled the criteria for the NO-ALS study and have completed the study
- Patients from both arm 1 and arm 2 in the NO-ALS study are allowed inclusion in the extension study
You will not qualify if you...
- Dementia, frontotemporal dementia (FTD), or other neurodegenerative disorder interfering with compliance
- Metabolic, neoplastic, or other physically or mentally debilitating disorder
- Patients who become tracheostomized as part of the treatment of ALS
- Patients with short expected survival at the discretion of the investigator
- Use of vitamin B3 or blueberry extracts outside the study
AI-Screening
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Trial Site Locations
Total: 17 locations
1
Haukeland University Hospital
Bergen, Norway
Actively Recruiting
2
Nordlandssykehuset HF
Bodø, Norway
Not Yet Recruiting
3
Vestre Viken HF
Drammen, Norway
Not Yet Recruiting
4
Helse Førde HF
Førde, Norway
Not Yet Recruiting
5
Helse Fonna HF
Haugesund, Norway
Not Yet Recruiting
6
Sørlandet sykehus
Kristiansand, Norway
Not Yet Recruiting
7
Sykehuset Innlandet HF
Lillehammer, Norway
Not Yet Recruiting
8
Akershus University Hospital
Lørenskog, Norway
Not Yet Recruiting
9
Helse Møre og Romsdal
Molde, Norway
Not Yet Recruiting
10
Helse Nord-Trøndelag HF
Namsos, Norway
Not Yet Recruiting
11
Oslo Univerity Hospital
Oslo, Norway
Not Yet Recruiting
12
Sykehuset Østfold HF
Sarpsborg, Norway
Not Yet Recruiting
13
Sykehuset i Telemark HF
Skien, Norway
Not Yet Recruiting
14
Stavanger University Hospital
Stavanger, Norway
Not Yet Recruiting
15
Universitetssykehuset Nord-Norge
Tromsø, Norway
Not Yet Recruiting
16
St. Olavs Hospital HF
Trondheim, Norway
Not Yet Recruiting
17
Sykehuset i Vestfold HF
Tønsberg, Norway
Not Yet Recruiting
Research Team
O
Ole-Bjørn Tysnes
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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