Actively Recruiting
Evaluation of the Combined Therapy of EH-301 and N-acetylcysteine Together With Riluzole in Amyotrophic Lateral Sclerosis (ALS)
Led by Biogipuzkoa Health Research Institute · Updated on 2026-02-17
90
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Combined Therapy of EH-301 and N-acetylcysteine Together With Riluzole in Amyotrophic Lateral Sclerosis (ALS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with ALS according to the Gold Coast criteria
- Disease duration 18 months or less
- Aged between 18 and 75 years
- Total ALSFRS-R score of 30 or higher
- Forced vital capacity (FVC) 70% or higher
- Receiving Riluzole (50 mg twice daily) for at least 30 days prior to study start and expected to continue
- Willing and able to follow study requirements
- Signed informed consent
- Women of childbearing potential agree to use highly effective contraception during study and 30 days before
- Men agree to use condoms combined with their partner's effective contraception during study
You will not qualify if you...
- Other neurodegenerative diseases
- Significant cognitive impairment or dementia
- Psychiatric illness interfering with study
- Use of high-dose vitamin B3 supplements within 30 days prior
- Severe heart disease
- Moderate to severe lung disease (e.g., emphysema, stage III-IV COPD)
- Uncontrolled chronic asthma
- Active cancer
- Any metabolic, neoplastic, or debilitating physical or mental disease affecting safety or results
- Genetically confirmed mitochondrial disease
- Tracheostomized or gastrostomized patients
- Participation in another clinical trial with investigational product within 30 days or five half-lives prior
- Clinically significant lab abnormalities affecting safety or compliance
- Allergy to NAC or excipients in study drugs
- Short life expectancy per investigator
- Women who are pregnant or breastfeeding and not surgically sterile or within 2 years postmenopause
- Unwillingness to use highly effective contraception during study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario Donostia
San Sebastián, Guipuzcoa, Spain, 20003
Actively Recruiting
Research Team
L
Lara Alameda Calvo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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