Clinical trialNCT03047629CompletedPhase 1/PHASE2Interventional

Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related Constipation

SponsorEnterin Inc.Enrollment50ConstipationParkinson's Disease

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Denise Barbut, MD FRCP
Enterin Inc.
Study Chair
clinicaltrials.gov ↗
Robert Hauser, MD MBA
University of South Florida
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
Steven Frucht, MD
NYU Langone Health
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

15 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Keck Hospital of University of Southern California
Los Angeles, California, United States
Rocky Mountain Movement Disorders Center, Pc
Englewood, Colorado, United States
Georgetown Universtiy, Department of Neurology
Washington D.C., District of Columbia, United States
Parkinson'S Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Neuroscience Research, University of Florida Jacksonville
Jacksonville, Florida, United States
Medsol Clinical Research
Port Charlotte, Florida, United States
Sarasota Memory Hospital Clinical Research Ctr.
Sarasota, Florida, United States
Suncoast Neuroscience Associates, Inc
St. Petersburg, Florida, United States
Usf Health Byrd Parkinson'S Disease Movement Disorders Center of Excellence
Tampa, Florida, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Movement Disorders Division, Mt. Sinai School of Medicine
New York, New York, United States
Riverhills Healthcare, Inc.
Cincinnati, Ohio, United States
Parkinson'S & Movement Disorders Center, Uh Cleveland Medical Center
Cleveland, Ohio, United States
Penn State Health, Department of Neurology
Hershey, Pennsylvania, United States
Thomas Jefferson University, Department of Neurology
Philadelphia, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ENT-01

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 11 May 2017
Primary completion: 25 Apr 2018
Completion: 14 Jun 2018
Last update posted: 27 Dec 2023
Registered enrollment: 50
Registry id: NCT03047629

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.