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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2023
  • participants needed
    300
  • sponsor
    Haukeland University Hospital
Updated on 3 November 2021
progressive disease
primary lateral sclerosis
riluzole

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 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 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 EH301 will decrease progression of motor symptoms and loss of vital capacity, and increase survival time in patients with ALS.

Details
Condition Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Disorders, Myelopathy, Amyotrophic Lateral Sclerosis, lou gehrig's disease
Treatment EH301 (Nicotinamide Riboside/Pterostilbene)
Clinical Study IdentifierNCT05095571
SponsorHaukeland University Hospital
Last Modified on3 November 2021

Eligibility

Yes No Not Sure

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, FTD or other neurodegenerative disorder interfereing 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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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