Clinical Trial

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

Study acronym: NADALS-001-ALS
Recruiting Phase 1/2
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07414212
Lead Sponsor Biogipuzkoa Health Research Institute
Conditions Amyotrophic Lateral Sclerosis
Enrollment 90 participants
Start Date 2025-11-25
Primary Completion 2026-11-25 (estimated)
Study Completion 2027-11-25 (estimated)
Updated on ClinicalTrials.gov 2026-02-17