NCT05423678 - 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)

Chio A, Canosa A, Gallo S, Cammarosano S, Moglia C, Fuda G, Calvo A, Mora G; PARALS group
ALS clinical trials: do enrolled patients accurately represent the ALS population? Neurology. 2011 Oct 11;77(15):1432-7. doi: 10.1212/WNL.0b013e318232ab9b. Epub 2011 Sep 28.
Powell JH, Fleming Y
Making medicines for America: the case for clinical trial diversity. J Natl Med Assoc. 2000 Nov;92(11):507-14. No abstract available.
Sabatelli M, Conte A, Zollino M
Clinical and genetic heterogeneity of amyotrophic lateral sclerosis. Clin Genet. 2013 May;83(5):408-16. doi: 10.1111/cge.12117. Epub 2013 Mar 12.

In Depth Observational Clinical Trial - Analyzing Participation Experiences Of Amyotrophic Lateral Sclerosis Patients

Clinical trial NCT05423678 - References