Research / Study

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

NCT05095571 · Active, not recruiting

Official study sources

ClinicalTrials.gov · NCT05095571

Official ClinicalTrials.gov Record ↗

Last verified: 09-30-2026 · ClinicalTrials.gov

Overview

Official title: A Randomized Placebo-controlled Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Study. Extension Protocol
Brief title: A Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Extension Study
Registration type: ClinicalTrials.gov
NCT number: NCT05095571
Status: Active, not recruiting
Study category: Interventional, Drug trial, ALS/FTD
Sponsor / center: Haukeland University Hospital
Research center: Not stated in the official study record.
Collaborators: Elysium Health
Study type: Interventional study
Phase: Not applicable / observational
Enrollment: 300
Start date: 10-07-2021
Primary completion date: 10-15-2026
Estimated / actual completion date: 10-15-2026
Last source update: 09-21-2026

What is being studied?

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.

Intervention(s)

EH301 (Nicotinamide Riboside/Pterostilbene)

Type: DIETARY_SUPPLEMENT

For this study EH301 is defined as Investigational Product(s) (IP). The ALS extension study is an open label study with active treatment of all patients thet have passed through the NO-ALS trial.

Who may be eligible?

This is a simplified summary. The official study team or research center determines eligibility.

Population / disease status: ALS-FTD where applicable, Diagnosed ALS
Diagnosis / conditions: Amyotrophic Lateral Sclerosis
Age: 35 Years to Not stated in the official study record.
Disease duration: Not stated in the official study record.
Respiratory criteria: Not stated in the official study record.
ALSFRS-R criteria: Not stated in the official study record.
Genetic criteria: Not stated in the official study record.
Medication requirements: Not stated in the official study record.

Major inclusion and exclusion criteria from the official record

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

Genetics

Gene-specific study?: No
Gene or variant: Any / Not gene-specific
Genetic test required?: Not stated in the official study record.
Known carrier required?: Not stated
Confirmed pathogenic variant required?: Not stated in the official study record.
Presymptomatic carriers eligible?: Not stated in the official study record.
At-risk relative eligible?: Not stated
Genetic test provided?: Not stated in the official study record.
Genetic counseling provided?: Not stated in the official study record.
Results returned / offered?: Not stated
Family history required?: Not stated in the official study record.

Study design

Randomized?: Not stated in the official study record.
Allocation: Not stated in the official study record.
Intervention model: Not stated in the official study record.
Masking: Not stated in the official study record.
Placebo: Not stated in the official study record.
Primary purpose: Not stated in the official study record.

Endpoints

Primary outcome measures

Incidence of adverse events

Secondary outcome measures

Disease progression as assessed by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R)
Change in vital capacity

A biomarker outcome should not automatically be interpreted as a clinical outcome.