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

Not Applicable

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Dietary Supplement: EH301 (Nicotinamide Riboside/Pterostilbene)

• Registration Number: NCT05095571
• Lead Sponsor: Haukeland University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-04
• Study Start: 2021-10-07
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NO-ALS Extension Study High Dose EH301	EH301 (Nicotinamide Riboside/Pterostilbene)	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Through study completion, 1 year	Studies of adverse events including changes in lab parameters induced by high dose oral NR/pterostilbene.

Secondary Outcome Measures

Name	Time	Method
Change in vital capacity	Determined after 12 months of follow-up.	Vital capacity measured by spirometry.
Disease progression as assessed by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R)	Determined after 12 months of follow-up.	ALSFRS-R is a validated rating instrument for monitoring the progression of disability in patients with ALS. The minimum score is 0 and the maximum score is 48, the higher score the more function is retained.

Trial Locations

Locations (17)

Sykehuset Østfold HF; 🇳🇴 Sarpsborg, Norway

St. Olavs Hospital HF; 🇳🇴 Trondheim, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Sørlandet sykehus; 🇳🇴 Kristiansand, Norway

Nordlandssykehuset HF; 🇳🇴 Bodø, Norway

Stavanger University Hospital; 🇳🇴 Stavanger, Norway

Sykehuset i Vestfold HF; 🇳🇴 Tønsberg, Norway

Vestre Viken HF; 🇳🇴 Drammen, Norway

Helse Førde HF; 🇳🇴 Førde, Norway

Sykehuset Innlandet HF; 🇳🇴 Lillehammer, Norway

Akershus University Hospital; 🇳🇴 Lørenskog, Norway

Oslo Univerity Hospital; 🇳🇴 Oslo, Norway

Universitetssykehuset Nord-Norge; 🇳🇴 Tromsø, Norway

Helse Møre og Romsdal; 🇳🇴 Molde, Norway

Helse Fonna HF; 🇳🇴 Haugesund, Norway

Helse Nord-Trøndelag HF; 🇳🇴 Namsos, Norway

Sykehuset i Telemark HF; 🇳🇴 Skien, Norway