Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety "Roll-over" Study (Rollover)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Constipation
- Parkinson Disease
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This is a Phase 2b, non-randomized, open-label study.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 30 years and 90 years
- Gender
- Both males and females
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 t...
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.
Tracking Information
- NCT #
- NCT04483479
- Collaborators
- Not Provided
- Investigators
- Study Chair: Michael Zasloff, MD, PhD Enterin Inc. Study Director: Denise Barbut, MD, FRCP Enterin Inc.
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