Amyotrophic Lateral SclerosisNCT05095571
A Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Extension Study
A study testing EH301 (Nicotinamide Riboside/Pterostilbene) in people with Amyotrophic Lateral Sclerosis, run by Haukeland University Hospital at 17 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- EH301 (Nicotinamide Riboside/Pterostilbene)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 17 sitesNorway
- Study dates
- 7 Oct 2021to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Norway17 sites
Haukeland University Hospital
Bergen
Nordlandssykehuset HF
Bodø
Vestre Viken HF
Drammen
Helse Førde HF
Førde
Helse Fonna HF
Haugesund
Sørlandet sykehus
Kristiansand
Sykehuset Innlandet HF
Lillehammer
Akershus University Hospital
Lørenskog
Helse Møre og Romsdal
Molde
Helse Nord-Trøndelag HF
Namsos
Oslo Univerity Hospital
Oslo
Sykehuset Østfold HF
Sarpsborg
Sykehuset i Telemark HF
Skien
Stavanger University Hospital
Stavanger
Sykehuset i Vestfold HF
Tønsberg
Universitetssykehuset Nord-Norge
Tromsø
St. Olavs Hospital HF
Trondheim
About this study
Official title: A Randomized Placebo-controlled Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Study. Extension Protocol
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.
Read more
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- EH301 (Nicotinamide Riboside/Pterostilbene)
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EH301 (Nicotinamide Riboside/Pterostilbene)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| NO-ALS Extension Study High Dose EH301 | Other | Not described Receives: Dietary Supplement: EH301 (Nicotinamide Riboside/Pterostilbene) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Studies of adverse events including changes in lab parameters induced by high dose oral NR/pterostilbene.
Measured: Through study completion, 1 year
Secondary outcomes (2)
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.
Measured: Determined after 12 months of follow-up.
Change in vital capacity
Vital capacity measured by spirometry.
Measured: Determined after 12 months of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start7 Oct 2021
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a multicenter open label study as a follow up of the NO-ALS trial. Newly diagnosed ALS cases were included in the study arm 1. Earlier ALS cases were included in study arm 2 to allow patients with earlier ALS to participate in the study as the treatment options outside the study were limited. The NO-ALS study will be stopped when we reach 180 patients in the group with newly diagnosed ALS cases (arm 1). This is the follow up study for patients completing 1 year follow up in the NO-ALS study.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Elysium Health
- Responsible party
- Sponsor
- Investigators
- Ole-Bjørn Tysnes, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095571
- Sponsor's protocol ID
- 266376
- Status last verified
- Sep 2026
- First submitted
- 4 Oct 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-controlled Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Study. Extension Protocol
- ClinicalTrials.gov ID
- NCT05095571
- Acronym / sponsor ID
- 266376
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Elysium Health
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a multicenter open label study as a follow up of the NO-ALS trial. Newly diagnosed ALS cases were included in the study arm 1. Earlier ALS cases were included in study arm 2 to allow patients with earlier ALS to participate in the study as the treatment options outside the study were limited. The NO-ALS study will be stopped when we reach 180 patients in the group with newly diagnosed ALS cases (arm 1). This is the follow up study for patients completing 1 year follow up in the NO-ALS study.
| Arm | Type | Receives |
|---|---|---|
| NO-ALS Extension Study High Dose EH301 | Other | Dietary Supplement: EH301 (Nicotinamide Riboside/Pterostilbene) |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | NO-ALS Extension Study High Dose EH301 |
Primary outcome
Incidence of adverse events
Time frame: Through study completion, 1 year
Studies of adverse events including changes in lab parameters induced by high dose oral NR/pterostilbene.
2 secondary outcomes
Disease progression as assessed by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R)
Time frame: Determined after 12 months of follow-up.
Change in vital capacity
Time frame: Determined after 12 months of follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole-Bjørn Tysnes principal investigator
Haukeland University Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EH301 (Nicotinamide Riboside/Pterostilbene) in people with Amyotrophic Lateral Sclerosis, run by Haukeland University Hospital at 17 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Through study completion, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.