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

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.