NCT04459091 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Aquilani R, Maestri R, Boselli M, Achilli MP, Arrigoni N, Bruni M, Dossena M, Verri M, Buonocore D, Pasini E, Barbieri A, Boschi F
The relationship between plasma amino acids and circulating albumin and haemoglobin in postabsorptive stroke patients. PLoS
Kimura Y, Yamada M, Kakehi T, Itagaki A, Tanaka N, Muroh Y
Combination of Low Body Mass Index and Low Serum Albumin Level Leads to Poor Functional Recovery in Stroke Patients. J Stroke Cerebrovasc Dis. 2017 Feb;26(2):448-453. doi: 10.1016/j.jstrokecerebrovasdis.2016.10.008. Epub 2016 Nov 14.
Rodriguez de Turco EB, Belayev L, Liu Y, Busto R, Parkins N, Bazan NG, Ginsberg MD
Systemic fatty acid responses to transient focal cerebral ischemia: influence of neuroprotectant therapy with human albumin. J Neurochem. 2002 Nov;83(3):515-24.

Effects of Supplementation With Amino Essential Acids on Circulating Albumin Levels in Patients With Cerebral Ictus in Rehabilitation Phase

Clinical trial NCT04459091 - References