Study Purpose:
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 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 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 EH301 will decrease progression of motor symptoms and loss of vital capacity, and increase survival time in patients with ALS.
Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Dietary Supplement
Intervention Name:
EH301 (Nicotinamide Riboside/Pterostilbene)
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Ole-Bjørn Tysnes, Haukeland University Hospital
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Ole-Bjørn Tysnes / email hidden; JavaScript is required / +4755975063
Study Sponsor:
Haukeland University Hospital
Estimated Enrollment:
300
Estimated Study Start Date:
10 / 07 / 2021
Estimated Study Completion Date:
10 / 31 / 2023
Posting Last Modified Date:
10 / 27 / 2021
Date Study Added to neals.org:
10 / 27 / 2021
Minimum Age:
35 Years
Maximum Age:
N/A
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, FTD or other neurodegenerative disorder interfereing 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
Haukeland University Hospital | Recruiting
Ole-Bjørn Tysnes / +4755975063/+4790686700 / email hidden; JavaScript is required
Principal Investigator : Ole-Bjørn Tysnes
Bergen
Norway
Helse Nord-Trøndelag HF | Not yet recruiting
Kristina Devik / +4798833255 / email hidden; JavaScript is required
Principal Investigator : Kristina Devik
Namsos
Norway
St. Olavs Hospital HF | Not yet recruiting
Helene Ballo Kvernmo / +4791167718 / email hidden; JavaScript is required
Principal Investigator : Helene Ballo Kvernmo
Trondheim
Norway
Universitetssykehuset Nord-Norge | Not yet recruiting
Margitta Kampmann
Principal Investigator : Margitta Kampmann
Tromsø
Norway
Stavanger University Hospital | Not yet recruiting
Katrin Ruth Schlüter / +4745236149 / email hidden; JavaScript is required
Principal Investigator : Katrin Ruth Schlüter
Stavanger
Norway
Sykehuset i Telemark HF | Not yet recruiting
Anne Berit Jøntvedt / +4747262912 / email hidden; JavaScript is required
Principal Investigator : Anne Berit Jøntvedt
Skien
Norway
Sykehuset Østfold HF | Not yet recruiting
Erika Hallerstig / +4798455652 / email hidden; JavaScript is required
Principal Investigator : Erika Hallerstig
Sarpsborg
Norway
Oslo Univerity Hospital | Not yet recruiting
Angelina Maniaol / +4797674106 / email hidden; JavaScript is required
Principal Investigator : Angelina Maniaol
Oslo
Norway
Helse Møre og Romsdal | Not yet recruiting
Åse Morsund / +4747756360 / email hidden; JavaScript is required
Principal Investigator : Åse Morsund
Molde
Norway
Nordlandssykehuset HF | Not yet recruiting
Espen Benjaminsen / +4748103893 / email hidden; JavaScript is required
Principal Investigator : Espen Benjaminsen
Bodø
Norway
Akershus University Hospital | Not yet recruiting
Ola Nakken / +4797659796 / email hidden; JavaScript is required
Principal Investigator : Ola Nakken
Lørenskog
Norway
Sykehuset Innlandet HF | Not yet recruiting
Grethe Kleveland / +4797157819 / email hidden; JavaScript is required
Principal Investigator : Grethe Kleveland
Lillehammer
Norway
Sørlandet sykehus | Not yet recruiting
Unn Ljøstad / +4741208824 / email hidden; JavaScript is required
Principal Investigator : Unn Ljøstad
Kristiansand
Norway
Helse Fonna HF | Not yet recruiting
Ineke HogenEsch / +4752732590 / email hidden; JavaScript is required
Principal Investigator : Ineke HogenEsch
Haugesund
Norway
Helse Førde HF | Not yet recruiting
Kristin Lif Breivik / +4793630457 / email hidden; JavaScript is required
Principal Investigator : Kristin Lif Breivik
Førde
Norway
Vestre Viken HF | Not yet recruiting
Ingrid Kristine Bjørnå / +4741339297 / email hidden; JavaScript is required
Principal Investigator : Ingrid Kristine Bjørnå
Drammen
Norway
Sykehuset i Vestfold HF | Not yet recruiting
Nicolai Johan Brun / +4793243780 / email hidden; JavaScript is required
Principal Investigator : Nicolai Johan Brun
Tønsberg
Norway