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

NCT05095571 | Recruiting

• 1 other identifier: 266376
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 17

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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Studies of adverse events including changes in lab parameters induced by high dose oral NR/pterostilbene.

  Through study completion, 1 year

Secondary Outcomes (2)

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

  Determined after 12 months of follow-up.

• Change in vital capacity

  Determined after 12 months of follow-up.

Other Outcomes (1)

• Overall survival

  Determined after 12 months of follow-up.

Study Arms (1)

NO-ALS Extension Study High Dose EH301

OTHER

Dietary Supplement: EH301 (Nicotinamide Riboside/Pterostilbene)

Interventions

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.

NO-ALS Extension Study High Dose EH301

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Elysium Health: collaborator

Study Sites (17)

Haukeland University Hospital

Bergen, Norway

RECRUITING

Nordlandssykehuset HF

Bodø, Norway

NOT YET RECRUITING

Vestre Viken HF

Drammen, Norway

NOT YET RECRUITING

Helse Førde HF

Førde, Norway

NOT YET RECRUITING

Helse Fonna HF

Haugesund, Norway

NOT YET RECRUITING

Sørlandet sykehus

Kristiansand, Norway

NOT YET RECRUITING

Sykehuset Innlandet HF

Lillehammer, Norway

NOT YET RECRUITING

Akershus University Hospital

Lørenskog, Norway

NOT YET RECRUITING

Helse Møre og Romsdal

Molde, Norway

NOT YET RECRUITING

Helse Nord-Trøndelag HF

Namsos, Norway

NOT YET RECRUITING

Oslo Univerity Hospital

Oslo, Norway

NOT YET RECRUITING

Sykehuset Østfold HF

Sarpsborg, Norway

NOT YET RECRUITING

Sykehuset i Telemark HF

Skien, Norway

NOT YET RECRUITING

Stavanger University Hospital

Stavanger, Norway

NOT YET RECRUITING

Universitetssykehuset Nord-Norge

Tromsø, Norway

NOT YET RECRUITING

St. Olavs Hospital HF

Trondheim, Norway

NOT YET RECRUITING

Sykehuset i Vestfold HF

Tønsberg, Norway

NOT YET RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

nicotinamide-beta-riboside; Pterocarpus marsupium

Condition Hierarchy (Ancestors)

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

Study Officials

• Ole-Bjørn Tysnes

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ole-Bjørn Tysnes

CONTACT

+4755975063; obty@haukeland.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a multicenter open label study as a follow up of the NO-ALS trial. Newly diagnosed ALS cases were included in the study arm 1. Earlier ALS cases were included in study arm 2 to allow patients with earlier ALS to participate in the study as the treatment options outside the study were limited. The NO-ALS study will be stopped when we reach 180 patients in the group with newly diagnosed ALS cases (arm 1). This is the follow up study for patients completing 1 year follow up in the NO-ALS study.

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 27, 2021
• Study Start: October 7, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

NO (17)