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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05095571
• Other study ID #: 266376
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Haukeland University Hospital
• Contact: Ole-Bjørn Tysnes
• Phone: +4755975063
• Email: obty[@]haukeland.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

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

Country	Name	City	State
Norway	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	Sykehuset i Vestfold HF	Tønsberg
Norway	Universitetssykehuset Nord-Norge	Tromsø
Norway	St. Olavs Hospital HF	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Elysium Health

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival	Defined as how many are alive or not requiring continuous respiratory ventilation life support.	Determined after 12 months of follow-up.
Primary	Incidence of adverse events	Studies of adverse events including changes in lab parameters induced by high dose oral NR/pterostilbene.	Through study completion, 1 year
Secondary	Disease progression as assessed by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R)	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.	Determined after 12 months of follow-up.
Secondary	Change in vital capacity	Vital capacity measured by spirometry.	Determined after 12 months of follow-up.