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

September 18, 2026 updated by: Haukeland University Hospital

A Randomized Placebo-controlled Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Study. Extension Protocol

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • Haukeland University Hospital
      • Bodø, Norway
        • Nordlandssykehuset HF
      • Drammen, Norway
        • Vestre Viken HF
      • Førde, Norway
        • Helse Førde HF
      • Haugesund, Norway
        • Helse Fonna HF
      • Kristiansand, Norway
        • Sørlandet sykehus
      • Lillehammer, Norway
        • Sykehuset Innlandet HF
      • Lørenskog, Norway
        • Akershus University Hospital
      • Molde, Norway
        • Helse Møre og Romsdal
      • Namsos, Norway
        • Helse Nord-Trøndelag HF
      • Oslo, Norway
        • Oslo Univerity Hospital
      • Sarpsborg, Norway
        • Sykehuset Østfold HF
      • Skien, Norway
        • Sykehuset i Telemark HF
      • Stavanger, Norway
        • Stavanger University Hospital
      • Tromsø, Norway
        • Universitetssykehuset Nord-Norge
      • Trondheim, Norway
        • St. Olavs Hospital HF
      • Tønsberg, Norway
        • Sykehuset i Vestfold HF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: NO-ALS Extension Study High Dose EH301
Dietary supplement: EH301 (Nicotinamide Riboside/Pterostilbene)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Through study completion, 1 year

Studies of adverse events including changes in lab parameters induced by high dose oral NR/pterostilbene.
Through study completion, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease progression as assessed by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R)
Time Frame: Determined after 12 months of follow-up.

ALSFRS-R is a validated rating instrument for monitoring the progression of disability in patients with ALS. The minimum score is 0 and the maximum score is 48, the higher score the more function is retained.
Determined after 12 months of follow-up.
Change in vital capacity
Time Frame: Determined after 12 months of follow-up.

Vital capacity measured by spirometry.
Determined after 12 months of follow-up.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Determined after 12 months of follow-up.

Defined as how many are alive or not requiring continuous respiratory ventilation life support.
Determined after 12 months of follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Collaborators

Elysium Health

Investigators

  • Principal Investigator: Ole-Bjørn Tysnes, Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2021

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 15, 2026

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2026

Last Update Submitted That Met QC Criteria

September 18, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 266376

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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