RecruitingNot ApplicableNCT05095571

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

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


Sponsor

Haukeland University Hospital

Enrollment

300 participants

Start Date

Oct 7, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 35 Years

Inclusion Criteria1

  • 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 Criteria5

  • 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

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Interventions

DIETARY_SUPPLEMENTEH301 (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.


Locations(17)

Haukeland University Hospital

Bergen, Norway

Nordlandssykehuset HF

Bodø, Norway

Vestre Viken HF

Drammen, Norway

Helse Førde HF

Førde, Norway

Helse Fonna HF

Haugesund, Norway

Sørlandet sykehus

Kristiansand, Norway

Sykehuset Innlandet HF

Lillehammer, Norway

Akershus University Hospital

Lørenskog, Norway

Helse Møre og Romsdal

Molde, Norway

Helse Nord-Trøndelag HF

Namsos, Norway

Oslo Univerity Hospital

Oslo, Norway

Sykehuset Østfold HF

Sarpsborg, Norway

Sykehuset i Telemark HF

Skien, Norway

Stavanger University Hospital

Stavanger, Norway

Universitetssykehuset Nord-Norge

Tromsø, Norway

St. Olavs Hospital HF

Trondheim, Norway

Sykehuset i Vestfold HF

Tønsberg, Norway

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NCT05095571


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