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

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: NCT05095571
Recruitment Status : Recruiting
First Posted : October 27, 2021
Last Update Posted : October 27, 2021
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 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.


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 : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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 pasients completing 1 year follow up in the NO-ALS study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Placebo-controlled Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Study. Extension Protocol
Actual Study Start Date : October 7, 2021
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2023


Arm Intervention/treatment
NO-ALS Extension Study High Dose EH301 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Disease progression as assessed by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) [ Time Frame: Determined after 12 months of follow-up. ]
    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.

  2. Change in vital capacity [ Time Frame: Determined after 12 months of follow-up. ]
    Vital capacity measured by spirometry.


Other Outcome Measures:
  1. Overall survival [ Time Frame: Determined after 12 months of follow-up. ]
    Defined as how many are alive or not requiring continuous respiratory ventilation life support.



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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:

  • 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

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): NCT05095571


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

Locations
Show Show 17 study locations
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: NCT05095571    
Other Study ID Numbers: 266376
First Posted: October 27, 2021    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021

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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
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Metabolic Diseases
Niacinamide
Niacin
Nicotinic Acids
Amyotrophic Lateral Sclerosis
TDP-43 Proteinopathies
Proteostasis Deficiencies
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents