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Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related Constipation
NCT03047629 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG ENT-01
Study Locations (15)
Florida
- Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton
- Neuroscience Research, University of Florida Jacksonville — Jacksonville
- MEDSOL Clinical Research — Port Charlotte
- Sarasota Memory Hospital Clinical Research Ctr. — Sarasota
- Suncoast Neuroscience Associates, Inc — St. Petersburg
- USF Health Byrd Parkinson's Disease Movement Disorders Center of Excellence — Tampa
Ohio
- Riverhills Healthcare, Inc. — Cincinnati
- Parkinson's & Movement Disorders Center, UH Cleveland Medical Center — Cleveland
Pennsylvania
- Penn State Health, Department of Neurology — Hershey
- Thomas Jefferson University, Department of Neurology — Philadelphia
California
- Keck Hospital of University of Southern California — Los Angeles
Colorado
- Rocky Mountain Movement Disorders Center, PC — Englewood
District of Columbia
- Georgetown Universtiy, Department of Neurology — Washington D.C.
Michigan
- Quest Research Institute — Farmington Hills
New York
- Movement Disorders Division, Mt. Sinai School of Medicine — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-05-11 |
| Est. Completion | 2018-06-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03047629
The ClinicalTrials.gov registry entry for NCT03047629 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Enterin, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03047629 reports 15 study locations spanning 8 distinct geographic areas — top geographies include Florida, Ohio, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03047629 about?
NCT03047629 is a clinical study titled "Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related Constipation". 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. ...
What is the current status of trial NCT03047629?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2017-05-11. Estimated completion is 2018-06-14.
What conditions does trial NCT03047629 study?
This clinical trial studies the following conditions: Parkinson's Disease, Constipation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03047629?
The interventions under investigation include: Placebo (OTHER), ENT-01 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03047629?
This trial is sponsored by Enterin, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03047629 being conducted?
This trial has 15 study locations across California, Colorado, District of Columbia, Florida, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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