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NCT Number: NCT05095571

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

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Bergen, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EH301 (Nicotinamide Riboside/Pterostilbene)

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Change in vital capacity

    Time frame: Determined after 12 months of follow-up.

    Vital capacity measured by spirometry.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ole-Bjørn Tysnes

CONTACT

[email protected]

+4755975063

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Elysium Health

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Oct 27, 2021
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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