The goal of this clinical trial is to learn if drug CB03-154 works to treat ALS in adults. It will also learn about the safety of drug CB03-154.
The main questions it aims to answer are:
* Does drug CB03-154 have an effect on delaying disease progression, improving function, and prolonging survival in adult ALS patients?
* What medical problems do patients have when taking drug CB03-154? Researchers will compare drug CB03-154 to a placebo (a look-alike substance that contains no drug) to see if drug CB03-154 works to treat ALS.
Participants (adult ALS patients) will:
* Take drug CB03-154 or a placebo every day for 39 weeks (an additional 39 weeks would be required if entering the open-label extension phase).
* Visit the clinic approximately every 2-3 months for checkups and tests, and there is also telephone follow-up in between.
* Keep a diary of daily medication (CB03-154 or other concomitant medications), and if there are any unplanned medications, the reason (disease or symptoms) also need be recorded.