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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04562831
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : March 22, 2022
Sponsor:
Collaborator:
Elysium Health
Information provided by (Responsible Party):
Haukeland University Hospital

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Dietary Supplement: EH301 (Nicotinamide Riboside/Pterostilbene) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Placebo-controlled Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Study
Actual Study Start Date : October 7, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022


Arm Intervention/treatment
Experimental: Newly diagnosed ALS patients
  1. High dose EH301 (1500mg Nicotinamide riboside / 300mg Pterostilbene)
  2. Single dose EH301 (1000mg Nicotinamide riboside / 200mg Pterostilbene)
  3. Placebo
Dietary Supplement: 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.

Experimental: Earlier diagnosed ALS patients
  1. High dose EH301 (1500mg Nicotinamide riboside / 300mg Pterostilbene)
  2. Placebo
Dietary Supplement: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in vital capacity [ Time Frame: Change from baseline to 1 year ]
    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.

  2. Change in cognitive functions as assessed by the Edinburgh Cognitive Scale (ECAS) [ Time Frame: Change from baseline to 1 year ]
    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.

  3. Change of Neurofilament light chain (NFL) levels in serum [ Time Frame: Change from baseline to 1 year ]
    NFL levels in serum, baseline values and changes during the study.

  4. Change in quality of life as assessed by the quality of life questionnaire SF-36 [ Time Frame: Change from baseline to 1 year ]
    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.


Other Outcome Measures:
  1. Overall survival [ Time Frame: Through study completion, 1 year ]
    Survival of patients through the study



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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).
  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04562831


Contacts
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Contact: Ole-Bjørn Tysnes +4755975063 obty@haukeland.no

Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Norway
Contact: Ole-Bjørn Tysnes         
Principal Investigator: Ole-Bjørn Tysnes         
Vestre Viken HF Recruiting
Drammen, Norway
Contact: Ingrid Kristine Bjørnå         
Principal Investigator: Ingrid Kristine Bjørnå         
Helse Førde HF Recruiting
Førde, Norway
Contact: Kristin Lif Breivik         
Principal Investigator: Kristin Lif Breivik         
Helse Fonna HF Recruiting
Haugesund, Norway
Contact: Ineke HogenEsch         
Principal Investigator: Ineke HogenEsch         
Akershus University Hospital Recruiting
Lørenskog, Norway
Contact: Ola Nakken         
Principal Investigator: Ola Nakken         
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Angelina Maniaol         
Principal Investigator: Angelina Maniaol         
Stavanger University Hospital Recruiting
Stavanger, Norway
Contact: Katrin Ruth Schlüter         
Principal Investigator: Katrin Ruth Schlüter         
Universitetssykehuset Nord-Norge Recruiting
Tromsø, Norway
Contact: Margitta Kampmann         
Principal Investigator: Margitta Kampmann         
St.Olavs Hospital HF Recruiting
Trondheim, Norway
Contact: Sigrid Botne Sando         
Principal Investigator: Sigrid Botne Sando         
Sponsors and Collaborators
Haukeland University Hospital
Elysium Health
Investigators
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Principal Investigator: Ole-Bjørn Tysnes Haukeland University Hospital
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT04562831    
Other Study ID Numbers: 98955
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: March 22, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents