Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET)
Public ClinicalTrials.gov record NCT03781791. 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, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease-Related Constipation (KARMET)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will be conducted as a multi-center, randomized, double-blind, placebo-controlled study. Approximately 72 patients will be randomized 3:1 to treatment or placebo, with approximately 54 patients allocated to receive the active investigational product and approximately 18 patients allocated to receive placebo. \- Study Update- Amendment 3 - In this amendment, an additional 80 patients (approximately) will be randomized 1:1 to treatment or placebo (double-blind) with approximately 40 subjects allocated to each group.
Study identification
- NCT ID
- NCT03781791
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 151 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
- Dec 10, 2018 (Actual)
- Primary completion
- Dec 14, 2021 (Actual)
- Completion
- Dec 14, 2021 (Actual)
- Last update posted
- Feb 20, 2024
2018 – 2021
United States locations
- U.S. sites
- 51
- U.S. states
- 26
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | — |
| Clinical Trials, Inc. | Little Rock | Arkansas | 72205 | — |
| The Parkinson's and Movement Disorder Institute | Fountain Valley | California | 92708 | — |
| Neuro Pain Medical Center | Fresno | California | 93710 | — |
| Pacific Neuroscience Medical Group | Oxnard | California | 93030 | — |
| SC3 Research - Pasadena | Pasadena | California | 91105 | — |
| Trial Connections - Care Access Research, Santa Clarita | Santa Clarita | California | 91321 | — |
| Rocky Mountain Movement Disorders Center | Englewood | Colorado | 80113 | — |
| Associated Neurologist of Southern CT | Fairfield | Connecticut | 06824 | — |
| Care Access Research, Norwich | Norwich | Connecticut | 06360 | — |
| Georgetown University Hospital | 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 | — |
| Elias Research - Floridian Research Institute | Miami | Florida | 33145 | — |
| Elias Research - Allied Biomedical Research Institute | Miami | Florida | 33155 | — |
| Pharmax Research of South Florida | Miami | Florida | 33175 | — |
| MEDSOL Clinical Research | Port Charlotte | Florida | 33952 | — |
| Parkinson's Disease Treatment Center of SWFL | Port Charlotte | Florida | 33980 | — |
| Intercoastal Medical Group | Sarasota | Florida | 34239 | — |
| University of South Florida | Tampa | Florida | 33603 | — |
| Palm Beach Neurology and Premier Research Institute | West Palm Beach | Florida | 33407 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| BTC Network - Community Clinical Research Center | Anderson | Indiana | 46011 | — |
| Interspond - The Neuromedical Clinic of Central Louisiana | Alexandria | Louisiana | 71301 | — |
| The NeuroMedical Center, P.C. | Baton Rouge | Louisiana | 70810 | — |
| Parkinson's and Movement Disorders Center of Maryland | Elkridge | Maryland | 21075 | — |
| Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | 48322 | — |
| Neurology Associates Clinical Research | Lincoln | Nebraska | 68506 | — |
| Interspond - Neurology Center of Las Vegas | Las Vegas | Nevada | 89128 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 13756 | — |
| Evolution Research Group - Neuroscience Research Institution | Toms River | New Jersey | 08755 | — |
| Neuroscience Researc Institute of NJ | Toms River | New Jersey | 08755 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | — |
| Wake Forest Baptist Medical Center | Wake Forest | North Carolina | 27157 | — |
| Dayton Center for Neurological Disorders | Centerville | Ohio | 45459 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic | Cleveland | Ohio | 44095 | — |
| Elias Research - Neurology Diagnostics Research | Dayton | Ohio | 45459 | — |
| University of Toledo Medical Center | Toledo | Ohio | 43614 | — |
| The Movement Disorder Clinic of Oklahoma | Tulsa | Oklahoma | 74136 | — |
| Penn State University | Hershey | Pennsylvania | 17033 | — |
| Interspond - Premier Neurology | Greer | South Carolina | 29650 | — |
| Interspond - Metrolina Neurological Associates | Old Point Station | South Carolina | 29707 | — |
| North Texas Movement Disorders Institute | Bedford | Texas | 76021 | — |
| BTC Network - Neurological Associates of North Texas | Dallas | Texas | 75218 | — |
| Clinical Trial Network | Houston | Texas | 77074 | — |
| Sentara Neuroscience Institute | Norfolk | Virginia | 23456 | — |
| 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 NCT03781791, 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 Feb 20, 2024 · 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 NCT03781791 live on ClinicalTrials.gov.