Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety "Roll-over" Study (Rollover)

Exclusion Criteria

• •1. Unable or unwilling to provide informed consent or to comply with study procedures.
• •2. Unable to withdraw proton pump inhibitors.
• •3. Unable or unwilling to withdraw from laxatives, opiates, clonazepam, or any medications which may cause constipation 2 weeks prior to the dose adjustment period and throughout the rest of the study.
• •4. Diagnosis of secondary constipation beyond that of Parkinson's disease.
• •5. A compromised gastrointestinal system which includes:
• •* Structural, metabolic, or functional GI diseases or disorders.
• •* Acute GI illness within 2 weeks of the screening visit.
• •* History of major GI surgery within 30 days of the screening visit (a history of cholecystectomy, polypectomy, hernia repair or appendicectomy are not exclusionary as long as they were performed more than 30 days before the screening visit).
• •6. Neurological disorder other than Parkinson's disease that in the opinion of the investigator might interfere with the conduct of the study.
• •7. On treatment with intra-jejunal dopamine or carbidopa/levodopa (i.e. Duopa).
• •8. Subjects starting a new Parkinson's disease medication or modifying an existing medication within 2 weeks prior to enrollment.
• •9. Unable to maintain a stable diet regimen.
• •10. Subjects with a cognitive impairment that preclude them from understanding the informed consent.
• •11. Subjects placed under legal guardianship.
• •12. History of excessive alcohol use or substance abuse.
• •13. Any clinically significant abnormalities on screening laboratories or physical examination requiring further evaluation or treatment.
• •14. Females who are pregnant or breastfeeding.
• •15. Subject or caregiver unable to administer daily oral dosing of study drug.
• •16. Participation in a non-Enterin investigational drug trial within the month prior to dosing in the present study.
• •17. Any other reason, which in the opinion of the investigator would confound proper interpretation of the study.