Actively Recruiting
Evaluation of NB-4746 Medication Compared to Placebo in Adults With Amyotrophic Lateral Sclerosis to Assess Safety and Effects
Led by Nura Bio · Updated on 2026-06-22
80
Participants Needed
8
Research Sites
43 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of the drug NB-4746 compared with a placebo in adults with amyotrophic lateral sclerosis ALS. This trial aims to understand the safety of NB-4746, how the drug moves through the body, and changes in a blood marker called neurofilament light NfL that reflects nerve cell damage. The study is conducted in two parts and includes an option for participants to join an open-label extension phase. In Part A, participants are randomly assigned to one of three groups low-dose NB-4746 capsules taken twice daily, high-dose NB-4746 capsules taken twice daily, or placebo capsules taken twice daily, all for about one month. In Part B, participants are randomly assigned to either NB-4746 at a dose determined from Part A or placebo, both taken twice daily for approximately 12 weeks. After completing Part A or B, participants may choose to enter an open-label extension to continue treatment for up to one year. During the trial, participants will have their ALS symptoms and overall health monitored regularly. The study team will assess safety by recording treatment-emergent adverse events and serious adverse events. Blood samples will be collected to measure NfL levels and evaluate drug movement in the body. Participants will be followed throughout the study and during the extension phase to track health status and treatment effects up to one year.
CONDITIONS
Brief Title
A Clinical Trial to Evaluate NB-4746 in Participants With Amyotrophic Lateral Sclerosis.
Research Team
L
Lahar Mehta, MD
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