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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIETARY_SUPPLEMENT

EH301 (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