NCT07414212 Evaluation of the Combined Therapy of EH-301 and N-acetylcysteine Together With Riluzole in Amyotrophic Lateral Sclerosis (ALS)
| NCT ID | NCT07414212 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Biogipuzkoa Health Research Institute |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-11-25 |
| Primary Completion | 2026-11-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2025-11-25 with a primary completion date of 2026-11-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Patients diagnosed with ALS according to the Gold Coast criteria; 2. Disease duration ≤ 18 months; 3. Men and women aged 18 to 75 years; 4. Total ALSFRS-R score ≥ 30 for all 12 categories; 5. Forced vital capacity (FVC) ≥70%; 6. The participant must receive treatment with Riluzole (50 mg twice daily) for ≥30 days prior to Day 1 (Visit 2) and is expected to remain on that dose until the final study visit. 7. Willingness and ability of the patient to comply with the requirements of the protocol during the study; 8. Sign written informed consent prior to any study-related procedure; 9. Acceptance by women to use at least one highly effective method of contraception during the study 30 days prior to taking the nutraceutical and investigational drug and throughout the study. The following are considered highly effective contraceptive methods: * Combined hormonal methods (oral, patches, injectables, or implants). * Hormonal or copper intrauterine devices (IUDs). * Previous surgical sterilization (bilateral tubal ligation). * Total sexual abstinence when consistent with the patient's usual lifestyle. 10. Acceptance by men included in the study of the use of condoms in combination with an effective contraceptive method used by their female partner of childbearing age during treatment. Exclusion Criteria: 1. Presence of other neurodegenerative diseases; 2. Significant cognitive impairment and/or dementia; 3. Any psychiatric illness that could interfere with the study; 4. Use of dietary supplements with high doses of vitamin B3 in the 30 days prior to inclusion in the study; 5. Severe heart disease; 6. Moderate to severe lung disease, such as emphysema, stage III-IV COPD; 7. Uncontrolled chronic asthma; 8. Active cancer; 9. Any metabolic, neoplastic, physically or mentally debilitating disease that could put the subject at risk or interfere with the study results; 10. Genetically confirmed mitochondrial disease; 11. Tracheostomized and/or gastrostomized patients; 12. Participation in any clinical trial with an investigational product within 30 days or five half-lives of the previous agent, whichever is longer, prior to dosing; 13. Any clinically significant laboratory abnormality that could directly affect compliance or safety; 14. Allergy to NAC or any excipient, either in the investigational drug or in the EH301 nutraceutical; 15. Patients with a short life expectancy in the investigator's judgment. 16. \[Women only\] Pregnancy or breastfeeding for women of childbearing potential (i.e., \<2 years postmenopausal or not surgically sterile); 17. The participant is unwilling to use highly effective contraception during the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07414212 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07414212 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07414212 currently recruiting?
Yes, NCT07414212 is actively recruiting participants. Contact the research team at lara.alamedacalvo@bio-gipuzkoa.eus for enrollment information.
Where is the NCT07414212 trial being conducted?
This trial is being conducted at San Sebastián, Spain.
Who is sponsoring the NCT07414212 clinical trial?
NCT07414212 is sponsored by Biogipuzkoa Health Research Institute. The trial plans to enroll 90 participants.
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