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

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.

Timeline

Start

2020-07-30

Primary completion

2022-02-17

Completion

2022-02-17

Outcome

Outcome not reported

Stopped (Enrollment): “Poor recruitment/retention due to the pandemic. Data was not analyzed due to early termination.”

Drugs

Indications