Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety "Roll-over" Study (Rollover)
Public ClinicalTrials.gov record NCT04483479. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04483479
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 27 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 30, 2020 (Actual)
- Primary completion
- Feb 17, 2022 (Actual)
- Completion
- Feb 17, 2022 (Actual)
- Last update posted
- Mar 19, 2024
2020 – 2022
United States locations
- U.S. sites
- 18
- U.S. states
- 10
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Parkinson's and Movement Disorder Institute | Fountain Valley | California | 92708 | — |
| SC3 Research - Pasadena | Pasadena | California | 91105 | — |
| Rocky Mountain Movement Disorders Center | Englewood | Colorado | 80113 | — |
| Georgetown Universtiy, Department of Neurology | Washington D.C. | District of Columbia | 20007 | — |
| JEM Research Institute | Atlantis | Florida | 33462 | — |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | — |
| Parkinson's Disease Treatment Center of SWFL | Port Charlotte | Florida | 33980 | — |
| Intercoastal Medical Group | Sarasota | Florida | 34239 | — |
| USF Health Byrd Parkinson's Disease Movement Disorders Center of Excellence | Tampa | Florida | 33613 | — |
| Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida | 33407 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 13756 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Cleveland Clinic | Cleveland | Ohio | 44095 | — |
| University of Toledo Medical Center | Toledo | Ohio | 43614 | — |
| Penn State University | Hershey | Pennsylvania | 17033 | — |
| Evergreen Health - Booth Gardner Parkinson's Care Center | Kirkland | Washington | 98034 | — |
| University Physicians & Surgeons, Inc. dba Marshall Health | Huntington | West Virginia | 25701 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04483479, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 19, 2024 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04483479 live on ClinicalTrials.gov.