Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2017-01-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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EH301
EH301
1-(beta-D-Ribofuranosyl)nicotinamide chloride and 3,5-Dimethoxy-4'-hydroxy-trans-stilbene
Placebo
Placebo
No intervention- placebo
Interventions
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EH301
1-(beta-D-Ribofuranosyl)nicotinamide chloride and 3,5-Dimethoxy-4'-hydroxy-trans-stilbene
Placebo
No intervention- placebo
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of probable or definite (sporadic or familial) ALS by El Escorial criteria
* Onset of symptomatology for more than 6 months
* If female: not lactating; negative pregnancy test; agree to use an effective method of birth control throughout study
Exclusion Criteria
* Gastrostomy
* Evidence of major psychiatric disorder or clinically evident dementia
* Diagnosis of a neurodegenerative disease in addition to ALS
* Current medication apart from riluzole that in the opinion of the investigator would make the patient unsuitable for study participation
* Recent history (within the previous 6 months) or current evidence of alcohol or drug abuse
* Concurrent unstable disease involving any system (e.g. carcinoma other than basal cell carcinoma), any cardiac dysrhythmia, myocardial infarction, clinical or ECG signs of myocardial ischemia, cardiac insufficiency, angina symptoms, current symptoms of coronary artery disease, or any other condition that in the opinion of the investigator would make the patient unsuitable for study participation
* Baseline QTc (Bazett) \> 450 msec for males and \> 470 msec for females
* Known hepatitis B/C or HIV positive serology
* Renal impairment defined as blood creatinine \> 2x ULN
* Hepatic impairment and/or liver enzymes (ALT or AST) \> 3x ULN
* Hemostasis disorders or current treatment with oral anticoagulants
* Participated in any other investigational drug or therapy study with a non-approved medication, within the previous 3 months
* No medical insurance
18 Years
ALL
No
Sponsors
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Fundación Universidad Católica de Valencia San Vicente Mártir
OTHER
University of Valencia
OTHER
Elysium Health
INDUSTRY
Responsible Party
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Locations
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Universidad Católica de Valencia San Vicente Màrtir
Valencia, , Spain
Countries
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References
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Carrera-Julia S, Estrela JM, Zacares M, Navarro MA, Vega-Bello MJ, de la Rubia Orti JE, Moreno ML, Drehmer E. Effect of the Mediterranean diet supplemented with nicotinamide riboside and pterostilbene and/or coconut oil on anthropometric variables in amyotrophic lateral sclerosis. A pilot study. Front Nutr. 2023 Sep 22;10:1232184. doi: 10.3389/fnut.2023.1232184. eCollection 2023.
Other Identifiers
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H1479983999044
Identifier Type: -
Identifier Source: org_study_id
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