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NCT03781791 · ClinicalTrials.gov registry record · Phase 2
Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET)
A Phase 2 study of Parkinson Disease and Constipation, sponsored by Enterin.
- Completed
- Registry status
- Phase 2
- Development phase
- 151
- Enrollment target
- 20
- Study locations
NCT03781791 is a Phase 2 study of Parkinson Disease and Constipation that has completed, run by Enterin. The registered enrollment target is 151 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT03781791, a Phase 2 study of Parkinson Disease and Constipation, has completed, sponsored by Enterin.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 151 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo Treatment
- DRUG Active Investigational Treatment ENT-01
Study Locations (20)
Florida
- JEM Research Institute - Atlantis
- Parkinson's Disease and Movement Disorders Center of Boca Raton - Boca Raton
- Elias Research - Floridian Research Institute - Miami
- Elias Research - Allied Biomedical Research Institute - Miami
- Pharmax Research of South Florida - Miami
- MEDSOL Clinical Research - Port Charlotte
- Parkinson's Disease Treatment Center of SWFL - Port Charlotte
- Intercoastal Medical Group - Sarasota
- University of South Florida - Tampa
California
- The Parkinson's and Movement Disorder Institute - Fountain Valley
- Neuro Pain Medical Center - Fresno
- Pacific Neuroscience Medical Group - Oxnard
- SC3 Research - Pasadena - Pasadena
- Trial Connections - Care Access Research, Santa Clarita - Santa Clarita
Connecticut
- Associated Neurologist of Southern CT - Fairfield
- Care Access Research, Norwich - Norwich
Arizona
- Banner Sun Health Research Institute - Sun City
Arkansas
- Clinical Trials, Inc. - Little Rock
Colorado
- Rocky Mountain Movement Disorders Center - Englewood
District of Columbia
- Georgetown University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2018-12-10 |
| Est. Completion | 2021-12-14 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03781791
The ClinicalTrials.gov registry entry for NCT03781791 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (97% lower). The listed sponsor is Enterin, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo Treatment is the first listed.
NCT03781791 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03781791 about?
NCT03781791 is a clinical study titled "Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET)". 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...
What is the current status of trial NCT03781791?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2018-12-10. Estimated completion is 2021-12-14.
What conditions does trial NCT03781791 study?
This clinical trial studies the following conditions: Parkinson Disease, Constipation.
What interventions are being tested in trial NCT03781791?
The interventions under investigation include: Placebo Treatment (DRUG), Active Investigational Treatment ENT-01 (DRUG).
Who is sponsoring clinical trial NCT03781791?
This trial is sponsored by Enterin, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03781791 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.