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NCT Number: NCT04562831

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

Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The average survival from the time of diagnosis is 3 years. Apart from Riluzole, there is no effective treatment. Care of advanced ALS will have a cost of 4-8 million NOK per year

Research i.a. from the investigators department has shown that increased activity in histone deacetylation enzymes (sirtuins) together with increased access to NAD can delay disease progression. Nicotinamide riboside (NR) can increase cells' access to NAD and Pterostilben will stimulate sirtuins.

The investigators want to study whether combination therapy with NR and Pterostilben can inhibit neurodegeneration in ALS and thereby delay disease development, increase survival and improve quality of life in ALS.

In the study, the investigators will use 2 different dosages on the active treatment and strength calculations show that 180 patients are needed to show a rather weak effect. Patients will be recruited in collaboration with hospitals in Helse Vest, AHUS, Drammen, OUS and St. Olavs hospital.

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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

Arm 1 (newly diagnosed ALS patients)

  • Have a clinical diagnosis of probable ALS according to the revised El Escorial criteria.
  • MR of the brain and cervical spine cannot explain symptoms.
  • Diagnosed with likely ALS within 6 months from enrolment and treated with Riluzole 50mg x 2
  • Symptom onset no longer than 2 year prior to inclusion.
  • ALS-FRC-R of 36 or more (not any item below 2).
  • Age equal to or greater than 35 years at time of enrollment

Arm 2 (earlier diagnosed ALS patients)

  • Have a clinical diagnosis of probable ALS according to the revised El Escorial criteria.
  • MR of the brain and cervical spine cannot explain symptoms.
  • Treated with Riluzole 50mg x 2.

Exclusion criteria

  • Dementia, FTD or other neurodegenerative disorder at baseline visit
  • Any psychiatric disorder that would interfere with compliance in the study.
  • Use of high dose vitamin B3 supplementation within 30 days of enrollment
  • Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.
  • Genetically confirmed mitochondrial disease
  • 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.

Treatment and study plan

EH301 (Nicotinamide Riboside/Pterostilbene)

Dietary Supplement

Comparison of 2 different dosages with placebo in newly diagnosed ALS patients and comparison of high dose with placebo in earlier ALS patients.

Primary outcomes

  1. Disease progression as assessed by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R)

    Time frame: Change from baseline to 1 year

    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.

Secondary outcomes

  1. Change in vital capacity

    Time frame: Change from baseline to 1 year

    Vital capacity in sitting position and supine by spirometry. Spirometry measures the amount of air that can be inhaled or exhaled and vital capacity is the volume of air breathed out after the deepest inhalation, the higher value the better vital capacity.

  2. Change in cognitive functions as assessed by the Edinburgh Cognitive Scale (ECAS)

    Time frame: Change from baseline to 1 year

    ECAS determines cognitive and behavioural changes of patients suffering from ALS. The minimum score is 0 and the maximum score is 136, the lower the score the greater the deficit.

  3. Change of Neurofilament light chain (NFL) levels in serum

    Time frame: Change from baseline to 1 year

    NFL levels in serum, baseline values and changes during the study.

  4. Change in quality of life as assessed by the quality of life questionnaire SF-36

    Time frame: Change from baseline to 1 year

    SF-36 is a 36-item patient-reported survey of patient health. The minimum score is 0 and the maximum score is 100. The higher the score the less disability.

Other outcomes

  1. Overall survival

    Time frame: Through study completion, 1 year

    Survival of patients through the study

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2020
Registry last updated
Jan 12, 2026

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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