NADALS-001-ALSNCT07414212

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

StatusRecruiting

PhasePhase 1/2

SponsorBiogipuzkoa Health Research Institute

Primary completionNov 25, 2026 (estimated)

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Record History

All 1 version: 1 with changes below.

Feb 10, 2026 Study First Submitted

Endpoints

Primary

ALSFRS-R scale

Timeframe: Up to 48 weeks

Secondary (8)

Muscle strength

Ventilation-free survival

Quality of life (ALSAQ-40)

Respiratory function (%FVC)

Time to gastrostomy

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Combined Assessment of Function and Survival (CAFS)

Neurofilament light chain (NfL) biomarker

Serum lipidomic profile

Arms and interventions

Acetylcysteine + EH301Experimental

Combination of 600 mg of NAC + 1800 mg of EH301 (1500 mg of NR + 300 mg of PTER) + 100 mg of Riluzole (standard treatment for both arms)

Acetylcysteine Placebo + EH301 PlaceboPlacebo comparator

Combination of NAC placebo + EH301 placebo + 100 mg of Riluzole (standard treatment for both arms)

Drugs: Acetylcysteine, Riluzole

Dietary supplements: EH301

Sites

1 site in 1 country

Hospital Universitario DonostiaSan Sebastián, Guipuzcoa, Spain

About this trial

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

Enrollment: 90 participants (estimated)
Started: Nov 25, 2025
Study completion: Nov 25, 2027 (estimated)
Eligibility: 18 to 75, all sexes, no healthy volunteers
Design: Interventional, randomized, triple blind, treatment
Conditions: Amyotrophic Lateral Sclerosis
Official title: A Phase II, Single-center, Randomized Double Blind, Placebo Controlled Study to Evaluate the Effect of the Combined Therapy of EH-301 and N-acetylcysteine Together With Riluzole in Ambulant Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)
First posted: Feb 17, 2026
Registry updated: Feb 17, 2026
Last verified: Feb 2026

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