NCT05095571 A Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Extension Study
| NCT ID | NCT05095571 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Haukeland University Hospital |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-10-07 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2021-10-07 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: Individuals will be excluded if any of the following exclusion criteria apply: * Dementia, fronto temporal 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. Such cases cannot be expected to follow protocol procedures. * Use of Vit B3 or blue berry extracts outside the study
Contact & Investigator
Ole-Bjørn Tysnes
PRINCIPAL INVESTIGATOR
Haukeland University Hospital
Frequently Asked Questions
Who can join the NCT05095571 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05095571 currently recruiting?
Yes, NCT05095571 is actively recruiting participants. Contact the research team at obty@haukeland.no for enrollment information.
Where is the NCT05095571 trial being conducted?
This trial is being conducted at Bergen, Norway, Bodø, Norway, Drammen, Norway, Førde, Norway and 11 additional locations.
Who is sponsoring the NCT05095571 clinical trial?
NCT05095571 is sponsored by Haukeland University Hospital. The principal investigator is Ole-Bjørn Tysnes at Haukeland University Hospital. The trial plans to enroll 300 participants.
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