ArticleAnnals of clinical and translational neurology2018
Pilot trial of inosine to elevate urate levels in amyotrophic lateral sclerosis.
Article in Annals of clinical and translational neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed, 44 citations in OpenAlex.
- Synthetic Data in Healthcare and Drug Development: Definitions, Regulatory Frameworks, Issues.CPT: pharmacometrics & systems pharmacology · 2025Review
- Xanthine Oxidoreductase: A Double-Edged Sword in Neurological Diseases.Antioxidants (Basel, Switzerland) · 2025Review
- Multifaceted role of inosine in complex diseases and human health.Nutrition reviews · 2025Review
- Targeting uric acid: a promising intervention against oxidative stress and neuroinflammation in neurodegenerative diseases.Cell communication and signaling : CCS · 2025Review
- Fasciculation potentials are related to the prognosis of amyotrophic lateral sclerosis.PloS one · 2024Article
- The Role of Uric Acid in Human Health: Insights from theJournal of personalized medicine · 2023Review
- Astrocytes: Dissecting Their Diverse Roles in Amyotrophic Lateral Sclerosis and Frontotemporal Dementia.Cells · 2023Review
- Uric acid and neurological disease: a narrative review.Frontiers in neurology · 2023Review
- Biologic targets of prescription medications and risk of neurodegenerative disease in United States Medicare beneficiaries.PloS one · 2023Article
- Inosine in Neurodegenerative Diseases: From the Bench to the Bedside.Molecules (Basel, Switzerland) · 2022Review
- Amyotrophic lateral sclerosis alters the metabolic aging profile in patient derived fibroblasts.Neurobiology of aging · 2021Article
- Motion correction methods for MRS: experts' consensus recommendations.NMR in biomedicine · 2021Article
- Inosine in Biology and Disease.Genes · 2021Review
- Advances in Proteomic and Metabolomic Profiling of Neurodegenerative Diseases.Frontiers in neurology · 2021Review
- Plasma Uric Acid Helps Predict Cognitive Impairment in Patients With Amyotrophic Lateral Sclerosis.Frontiers in neurology · 2021Article
- Mitochondrial Dysfunctions: A Red Thread across Neurodegenerative Diseases.International journal of molecular sciences · 2020Review
- Metabolomics: A Tool to Understand the Impact of Genetic Mutations in Amyotrophic Lateral Sclerosis.Genes · 2020Review
Corrections and comments
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Authors and funding
17 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo test the safety, tolerability, and urate-elevating capability of the urate precursor inosine taken orally or by feeding tube in people with amyotrophic lateral sclerosis (ALS).
methodsThis was a pilot, open-label trial in 25 participants with ALS. Treatment duration was 12 weeks. The dose of inosine was titrated at pre-specified time points to elevate serum urate levels to 7-8 mg/dL. Primary outcomes were safety (as assessed by the occurrence of adverse events [AEs]) and tolerability (defined as the ability to complete the 12-week study on study drug). Secondary outcomes included biomarkers of oxidative stress and damage. As an exploratory analysis, observed outcomes were compared with a virtual control arm built using prediction algorithms to estimate ALSFRS-R scores.
resultsTwenty-four out of 25 participants (96%) completed 12 weeks of study drug treatment. One participant was unable to comply with study visits and was lost to follow-up. Serum urate rose to target levels in 6 weeks. No serious AEs attributed to study drug and no AEs of special concern, such as urolithiasis and gout, occurred. Selected biomarkers of oxidative stress and damage had significant changes during the study period. Observed changes in ALSFRS-R did not differ from baseline predictions.
interpretationInosine appeared safe, well tolerated, and effective in raising serum urate levels in people with ALS. These findings, together with epidemiological observations and preclinical data supporting a neuroprotective role of urate in ALS models, provide the rationale for larger clinical trials testing inosine as a potential disease-modifying therapy for ALS.
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.