Amyotrophic Lateral SclerosisNCT04562831
The NO-ALS Study: A Trial of Nicotinamide/Pterostilbene Supplement in ALS.
A study testing EH301 (Nicotinamide Riboside/Pterostilbene) in people with Amyotrophic Lateral Sclerosis, run by Haukeland University Hospital at 9 sites in Norway.
Trial summary
Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The average survival from the time of diagnosis is 3 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. 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
- 380 participants
- Where
- 9 sitesNorway
- Study dates
- 7 Oct 2020to 31 Oct 2027
- 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
- Arm 1 (newly diagnosed ALS patients)
- Have a clinical diagnosis of probable ALS according to the revised El Escorial criteria.
- MR of the brain and cervical spine cannot explain symptoms.
- Diagnosed with likely ALS within 6 months from enrolment and treated with Riluzole 50mg x 2
- Symptom onset no longer than 2 year prior to inclusion.
- ALS-FRC-R of 36 or more (not any item below 2).
Show all 11Show fewer
- Age equal to or greater than 35 years at time of enrollment
- Arm 2 (earlier diagnosed ALS patients)
- Have a clinical diagnosis of probable ALS according to the revised El Escorial criteria.
- MR of the brain and cervical spine cannot explain symptoms.
- Treated with Riluzole 50mg x 2.
Who cannot join
- Dementia, FTD or other neurodegenerative disorder at baseline visit
- Any psychiatric disorder that would interfere with compliance in the study.
- Use of high dose vitamin B3 supplementation within 30 days of enrollment
- Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.
- Genetically confirmed mitochondrial disease
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Norway9 sites
Haukeland University Hospital
Bergen
Vestre Viken HF
Drammen
Helse Førde HF
Førde
Helse Fonna HF
Haugesund
Akershus University Hospital
Lørenskog
Oslo University Hospital
Oslo
Stavanger University Hospital
Stavanger
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
Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The average survival from the time of diagnosis is 3 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.
Read more
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 study, the investigators will use 2 different dosages on the active treatment and strength calculations show that 180 patients are needed to show a rather weak effect. Patients will be recruited in collaboration with hospitals in Helse Vest, AHUS, Drammen, OUS and St. Olavs hospital.
- 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
Comparison of 2 different dosages with placebo in newly diagnosed ALS patients and comparison of high dose with placebo in earlier ALS patients.
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed ALS patients | Experimental | 1. High dose EH301 (1500mg Nicotinamide riboside / 300mg Pterostilbene)
2. Single dose EH301 (1000mg Nicotinamide riboside / 200mg Pterostilbene)
3. Placebo Receives: Dietary Supplement: EH301 (Nicotinamide Riboside/Pterostilbene) |
| Earlier diagnosed ALS patients | Experimental | 1. High dose EH301 (1500mg Nicotinamide riboside / 300mg Pterostilbene)
2. Placebo Receives: Dietary Supplement: EH301 (Nicotinamide Riboside/Pterostilbene) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Change from baseline to 1 year
Secondary outcomes (4)
Change in vital capacity
Vital capacity in sitting position and supine by spirometry. Spirometry measures the amount of air that can be inhaled or exhaled and vital capacity is the volume of air breathed out after the deepest inhalation, the higher value the better vital capacity.
Measured: Change from baseline to 1 year
Change in cognitive functions as assessed by the Edinburgh Cognitive Scale (ECAS)
ECAS determines cognitive and behavioural changes of patients suffering from ALS. The minimum score is 0 and the maximum score is 136, the lower the score the greater the deficit.
Measured: Change from baseline to 1 year
Change of Neurofilament light chain (NFL) levels in serum
NFL levels in serum, baseline values and changes during the study.
Measured: Change from baseline to 1 year
Change in quality of life as assessed by the quality of life questionnaire SF-36
SF-36 is a 36-item patient-reported survey of patient health. The minimum score is 0 and the maximum score is 100. The higher the score the less disability.
Measured: Change from baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start7 Oct 2020
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 380 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
- NCT04562831
- Sponsor's protocol ID
- 98955
- Status last verified
- Jan 2026
- First submitted
- 10 Sep 2020
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 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
- ClinicalTrials.gov ID
- NCT04562831
- Acronym / sponsor ID
- 98955
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Elysium Health
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 24 Sep 2020 (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 average survival from the time of diagnosis is 3 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 study, the investigators will use 2 different dosages on the active treatment and strength calculations show that 180 patients are needed to show a rather weak effect. Patients will be recruited in collaboration with hospitals in Helse Vest, AHUS, Drammen, OUS and St. Olavs hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed ALS patients | Experimental | Dietary Supplement: EH301 (Nicotinamide Riboside/Pterostilbene)1. High dose EH301 (1500mg Nicotinamide riboside / 300mg Pterostilbene) 2. Single dose EH301 (1000mg Nicotinamide riboside / 200mg Pterostilbene) 3. Placebo |
| Earlier diagnosed ALS patients | Experimental | Dietary Supplement: EH301 (Nicotinamide Riboside/Pterostilbene)1. High dose EH301 (1500mg Nicotinamide riboside / 300mg Pterostilbene) 2. Placebo |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Arm 1 (newly diagnosed ALS patients)
- Have a clinical diagnosis of probable ALS according to the revised El Escorial criteria.
- MR of the brain and cervical spine cannot explain symptoms.
- Diagnosed with likely ALS within 6 months from enrolment and treated with Riluzole 50mg x 2
- Symptom onset no longer than 2 year prior to inclusion.
Key exclusion criteria (7 listed)
- Dementia, FTD or other neurodegenerative disorder at baseline visit
- Any psychiatric disorder that would interfere with compliance in the study.
- Use of high dose vitamin B3 supplementation within 30 days of enrollment
- Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.
- Genetically confirmed mitochondrial disease
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)Comparison of 2 different dosages with placebo in newly diagnosed ALS patients and comparison of high dose with placebo in earlier ALS patients. | Dietary supplement | Earlier diagnosed ALS patients, Newly diagnosed ALS patients |
Primary outcome
Disease progression as assessed by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R)
Time frame: Change from baseline to 1 year
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.
4 secondary outcomes
Change in vital capacity
Time frame: Change from baseline to 1 year
Change in cognitive functions as assessed by the Edinburgh Cognitive Scale (ECAS)
Time frame: Change from baseline to 1 year
Change of Neurofilament light chain (NFL) levels in serum
Time frame: Change from baseline to 1 year
Change in quality of life as assessed by the quality of life questionnaire SF-36
Time frame: Change from baseline to 1 year
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 5 Oct 2026.
- Individual participant dataSharing planned: No
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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
9 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 9 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 11 inclusion and 7 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Disease progression as assessed by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) (time frame: Change from baseline to 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 5 Oct 2026.