RT001 in Amyotrophic Lateral Sclerosis

Exclusion Criteria

• •1. Received treatment with other experimental therapies within the last 30 days prior to the first dose
• •2. Previously received treatment with RT001
• •3. Refusal to discontinue fish oils or other oil-based supplements for the duration of the study (Screening till last study procedure completed)
• •4. SVC \< 70 at screening
• •5. Subject has a feeding tube or the need for a feeding tube is anticipated within the first 24 weeks after enrollment
• •6. Subject resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period
• •7. Evidence of any clinically significant neurological disorder other than ALS
• •8. The subject has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or ICD-10 criteria
• •9. The subject has a significant pulmonary disorder not attributed to ALS or who require treatments that might complicate the evaluation of the effect of ALS on respiratory function
• •10. Subject has had a significant illness or infection requiring medical intervention in the past 30 days
• •11. Female who is breastfeeding or has a positive pregnancy test
• •12. Male participant or female participant of childbearing potential, who is sexually active and unwilling/unable to use a medically acceptable and effective double barrier birth control method throughout the study
• •13. Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to return for visits as scheduled
• •14. History, within the last 2 years, of alcohol abuse or physical opioid dependence