A Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Extension Study
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|ClinicalTrials.gov Identifier: NCT05095571|
Recruitment Status : Recruiting
First Posted : October 27, 2021
Last Update Posted : October 27, 2021
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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)|
|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|
|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.
- 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.
- 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.
- Change in vital capacity [ Time Frame: Determined after 12 months of follow-up. ]Vital capacity measured by spirometry.
- 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.
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
|Contact: Ole-Bjørn Tysnesfirstname.lastname@example.org|
|Principal Investigator:||Ole-Bjørn Tysnes||Haukeland University Hospital|