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MinorCompletion pushed from Oct 31, 2026 to Oct 31, 2027Interventions: EH301 (Nicotinamide Riboside/Pterostilbene) (Dietary Supplement) to EH301 (Nicotinamide Riboside/Pterostilbene) (Dietary Supplement) · Eligibility criteria expanded, about 16 words · Secondary endpoints: details revised at 3 of 4 entriesShow 3 more changesShow less
Secondary endpoints: details revised at 3 of 4 entries
NotablePrimary and study completion dates: Aug 31, 2025 to Oct 31, 2026Trial status: Recruiting to Active, Not Recruiting · Site details revised at 9 of 9 sitesv9Show 2 more changesShow less
Trial status: Recruiting to Active, Not Recruiting
Site details revised at 9 of 9 sites
MinorSite contacts updated at 9 of 9 sitesv8
NotablePrimary and study completion dates: Oct 2022 to Aug 31, 2025v7
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 8 to 9 · Start date changed from estimate of Sep 2020 to Oct 7, 2020v2Show 2 more changesShow less
Study sites: 8 to 9
Start date changed from estimate of Sep 2020 to Oct 7, 2020
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.