Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related Constipation

Exclusion Criteria

• •1. Unable or unwilling to provide informed consent or to comply with study procedures
• •2. Diagnosis of secondary constipation beyond that of PD
• •3. Structural or metabolic diseases that affect the GI system
• •4. Functional GI disorder
• •5. Unable or unwilling to withdraw from taking the following medications 2 weeks prior to the dose-escalation period and throughout the study: Laxatives, opiates, sedatives, hypnotics, anti-histamines, protein pump inhibitors or any medications which may cause constipation
• •6. History of recent major surgery (within 60 days of screening)
• •7. Any clinically significant abnormalities on screening laboratories or physical examination as determined by the Investigator
• •8. Neurological disorder other than PD
• •9. On treatment with intra-jejunal dopamine
• •10. Treatment with COMT inhibitors for fewer than 4 weeks (entacapone, tolcapone, Stalevo)
• •11. Unable to maintain a stable diet regimen
• •12. Patients with a cognitive impairment that preclude them from understanding the informed consent
• •13. Patients placed under legal guardianship
• •14. Acute GI illness within 48 hours of the baseline period
• •15. History of major GI surgery (e.g. previous abdominal surgery, including cholecystectomy), except that patients with uncomplicated appendectomy are allowed
• •16. ALT or AST \> 1.5 X upper limit of normal (ULN) during screening
• •17. Females who are pregnant or breastfeeding
• •18. History of excessive alcohol use or substance abuse
• •19. Patient or caregiver unable to administer daily oral dosing
• •20. Participation in an investigational clinical study within the 6 months prior to dosing in the present study
• •21. Any other reason, which in the opinion of the Investigator would confound proper interpretation of the study