Amisodin for ALS

(ALS Trial)

This trial tests the safety and tolerance of a new oral drug, Amisodin. It aims to understand how the body processes this drug, potentially aiding future treatments for conditions like ALS, which affects nerve cells in the brain and spinal cord. Participants will receive either Amisodin or a placebo (a harmless pill with no active drug) in varying doses to observe its effects in the body. Ideal candidates for this trial are healthy adults who do not smoke and have no significant medical issues. As a Phase 1 trial, participants will be among the first to receive this new treatment, assisting researchers in understanding its effects in people.

Yes, you will need to stop taking any prescription or non-prescription medications, herbal remedies, or vitamin supplements 14 days before the trial starts. Additionally, you must avoid certain drugs that affect liver enzymes for 28 days before the trial.

Previous studies have examined the safety and pharmacokinetics of Amisodin, a new drug for ALS, a disease that weakens muscles. Although specific safety data is not yet available, this trial is in its early stages. The main goal is to determine if Amisodin is safe and well-tolerated in healthy adults. Early-stage trials often mark the first time a drug is tested in humans, making safety a key focus. If Amisodin proves safe in this group, it can proceed to further testing.¹²³⁴⁵

Unlike the standard treatments for ALS, which often focus on managing symptoms, Amisodin offers a potentially new approach by targeting the disease at its core. Researchers are excited about Amisodin because it is designed to be administered orally, making it more convenient than many existing therapies that require injections or infusions. Additionally, Amisodin is being tested in both single and multiple ascending doses, which could provide flexibility in treatment options and dosing regimens. This novel delivery and dosing strategy, combined with its unique mechanism of action, sets Amisodin apart and fuels hope for improved outcomes in ALS care.

Research has shown that Amisodin might help people with ALS, a disease affecting nerve cells in the brain and spinal cord. In studies with mice having a condition similar to ALS, Amisodin improved their muscle strength and mobility. It also preserved the health of nerve cells needed for movement. This trial will compare Amisodin with a placebo to evaluate its effectiveness in humans. Participants will be randomly assigned to receive either Amisodin or a placebo. However, further research is needed to confirm its effectiveness in humans.⁴⁵⁶⁷⁸