NCT04483479

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

A Multicenter, Non-Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered ENT-01 in Improving Constipation and Neurologic Symptoms in Patients With Parkinson's Disease and Constipation Over a 14-week Period

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Enterin Inc. · Industry
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will be conducted on an out-patient or in-patient basis with visits performed at the screening visit, at 6 and 12 weeks, and at the end of the 6th week of the wash-out period (end of study). The dose escalation period will last up to 20 days, the fixed dose period will last 12 weeks, and the wash-out period will last 6 weeks. Subjects will begin dosing at the same dose level they were stratified to in the ENT-01-030 randomized study (i.e., starting at either 3 tablets or 6 tablets,) and escalate up to a pro-kinetic dose or a maximum dose of 250mg.

Conditions

• Parkinson Disease
• Constipation

Interventions

Type	Name	Description
DRUG	Active Investigational Treatment ENT-01	ENT-01 will be administered in tablet form, once daily in escalating doses followed by a fixed-dose for 12 weeks.

Timeline

• Start date: 2020-07-30
• Primary completion: 2022-02-17
• Completion: 2022-02-17
• First posted: 2020-07-23
• Last updated: 2024-03-19
• Results posted: 2024-03-19

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study