Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety "Roll-over" Study (Rollover)
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
This study will be conducted as an open-label safety follow-on to a multi-center,
double-blind, randomized study. All subjects who participated in the randomized study will be
offered participation in this unblinded, single-arm, safety study. Approximately 50 subjects
will be entered into the study and ENT-01 will be administered daily in escalating doses
followed by a fixed dose for 12 weeks. Each subject will participate for approximately 20
weeks; dosing duration will be approximately 14 weeks.