Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related Constipation
Public ClinicalTrials.gov record NCT03047629. 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 Multi-Center, Single-Dose, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Related Constipation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 1/2a study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of an orally-administered medication to relieve symptoms of constipation associated with Parkinson's Disease. Ten patients will be enrolled in Phase 1, and will be studied over an 8-12 week period. Forty patients will be enrolled in Phase 2, and will be studied over an 8-10 week period. All subjects will receive the study drug during one of the observational periods of the study.
Study identification
- NCT ID
- NCT03047629
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 Years to 86 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
- May 11, 2017 (Actual)
- Primary completion
- Apr 25, 2018 (Actual)
- Completion
- Jun 14, 2018 (Actual)
- Last update posted
- Dec 27, 2023
2017 – 2018
United States locations
- U.S. sites
- 15
- U.S. states
- 8
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Keck Hospital of University of Southern California | Los Angeles | California | 90033 | — |
| Rocky Mountain Movement Disorders Center, PC | Englewood | Colorado | 80113 | — |
| Georgetown Universtiy, Department of Neurology | Washington D.C. | District of Columbia | 20007 | — |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | — |
| Neuroscience Research, University of Florida Jacksonville | Jacksonville | Florida | 32209 | — |
| MEDSOL Clinical Research | Port Charlotte | Florida | 33952 | — |
| Sarasota Memory Hospital Clinical Research Ctr. | Sarasota | Florida | 34239 | — |
| Suncoast Neuroscience Associates, Inc | St. Petersburg | Florida | 33713 | — |
| USF Health Byrd Parkinson's Disease Movement Disorders Center of Excellence | Tampa | Florida | 33613 | — |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | — |
| Movement Disorders Division, Mt. Sinai School of Medicine | New York | New York | 10029 | — |
| Riverhills Healthcare, Inc. | Cincinnati | Ohio | 45212 | — |
| Parkinson's & Movement Disorders Center, UH Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Penn State Health, Department of Neurology | Hershey | Pennsylvania | 17033 | — |
| Thomas Jefferson University, Department of Neurology | Philadelphia | Pennsylvania | 19107 | — |
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 NCT03047629, 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 Dec 27, 2023 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03047629 live on ClinicalTrials.gov.