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

Sponsor
Biogipuzkoa Health Research Institute
Study ID
NCT07414212
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Acetylcysteine — DRUG
    Daily dose of 600mg of effervescent powder
  • EH301 — DIETARY_SUPPLEMENT
    Daily dose of 1800mg of capsules
  • Riluzole — DRUG
    Daily dose of 100mg of tablets

Study Details

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.

Key Dates

First listed
Feb 17, 2026
Start date
Nov 25, 2025
Status verified
Feb 2026
Primary completion
Nov 25, 2026
Completion
Nov 25, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Acetylcysteine + EH301
    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)
  • Placebo Comparator: Acetylcysteine Placebo + EH301 Placebo
    Combination of NAC placebo + EH301 placebo + 100 mg of Riluzole (standard treatment for both arms)

Primary Outcome Measure

ALSFRS-R scale [ Time Frame: Up to 48 weeks ]

Central Contacts

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