drugset / Trial / NCT07414212

Evaluation of the Combined Therapy of EH-301 and N-acetylcysteine Together With Riluzole in Amyotrophic Lateral Sclerosis (ALS)

NCT07414212

Phase 1/2 Recruiting 90 enrolled Biogipuzkoa Health Research Institute
RandomizedParallel-groupTriple-blindTreatment

Summary

This study is designed to evaluate whether a combination of N-acetylcysteine (NAC) and EH-301 can slow down or improve symptoms of amyotrophic lateral sclerosis (ALS). Researchers will assess changes in disease progression using the ALS Functional Rating Scale-Revised (ALSFRS-R), a standard tool for measuring daily functioning in people with ALS. The main question is whether taking NAC together with EH-301 can prevent symptom worsening and possibly improve existing ALS symptoms. Participants will be randomly assigned to receive either the active combination (NAC + EH-301) or matching placebos for 6 months. During this period, they will attend regular clinic visits for evaluations, tests, and safety monitoring. After completing the initial 6-month phase, all participants may choose to join a 6-month open-label extension, where everyone receives the active treatment regardless of their original group.

Timeline

Start
2025-11-25
Primary completion
2026-11-25
Completion
2027-11-25

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 600 mg
Background Riluzole Small molecule 100 mg