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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05095571
Other study ID # 266376
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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