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| Name | Class |
|---|---|
| Elysium Health | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NO-ALS Extension Study High Dose EH301 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Studies of adverse events including changes in lab parameters induced by high dose oral NR/pterostilbene. | Through study completion, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Determined after 12 months of follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Defined as how many are alive or not requiring continuous respiratory ventilation life support. | Determined after 12 months of follow-up. |
Inclusion Criteria:
Exclusion Criteria:
Individuals will be excluded if any of the following exclusion criteria apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ole-Bjørn Tysnes | Contact | +4755975063 | obty@haukeland.no |
| Name | Affiliation | Role |
|---|---|---|
| Ole-Bjørn Tysnes | Haukeland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Recruiting | Bergen | Norway |
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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.
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| Change in vital capacity | Vital capacity measured by spirometry. | Determined after 12 months of follow-up. |
| Nordlandssykehuset HF | Not yet recruiting | Bodø | Norway |
|
| Vestre Viken HF | Not yet recruiting | Drammen | Norway |
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| Helse Førde HF | Not yet recruiting | Førde | Norway |
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| Helse Fonna HF | Not yet recruiting | Haugesund | Norway |
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| Sørlandet sykehus | Not yet recruiting | Kristiansand | Norway |
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| Sykehuset Innlandet HF | Not yet recruiting | Lillehammer | Norway |
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| Akershus University Hospital | Not yet recruiting | Lørenskog | Norway |
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| Helse Møre og Romsdal | Not yet recruiting | Molde | Norway |
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| Helse Nord-Trøndelag HF | Not yet recruiting | Namsos | Norway |
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| Oslo Univerity Hospital | Not yet recruiting | Oslo | Norway |
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| Sykehuset Østfold HF | Not yet recruiting | Sarpsborg | Norway |
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| Sykehuset i Telemark HF | Not yet recruiting | Skien | Norway |
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| Stavanger University Hospital | Not yet recruiting | Stavanger | Norway |
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| Universitetssykehuset Nord-Norge | Not yet recruiting | Tromsø | Norway |
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| St. Olavs Hospital HF | Not yet recruiting | Trondheim | Norway |
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| Sykehuset i Vestfold HF | Not yet recruiting | Tønsberg | Norway |
|
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C018613 | nicotinamide-beta-riboside |
| C000721168 | Pterocarpus marsupium |
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