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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 11, 2017

Primary Completion Date

April 25, 2018

Study Completion Date

June 14, 2018

Conditions
Parkinson's DiseaseConstipation
Interventions
DRUG

ENT-01

Daily dosing with ENT-01. ENT-01 is an orally administered proprietary substance formulated as a small 25mg coated tablet. Dosing will range from 25-200mg, and the dose will be taken upon awakening on an empty stomach with 8oz water simultaneous to dopamine.

OTHER

Placebo

Daily dosing with a placebo

Trial Locations (15)

10029

Movement Disorders Division, Mt. Sinai School of Medicine, New York

17033

Penn State Health, Department of Neurology, Hershey

19107

Thomas Jefferson University, Department of Neurology, Philadelphia

20007

Georgetown Universtiy, Department of Neurology, Washington D.C.

32209

Neuroscience Research, University of Florida Jacksonville, Jacksonville

33486

Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton

33613

USF Health Byrd Parkinson's Disease Movement Disorders Center of Excellence, Tampa

33713

Suncoast Neuroscience Associates, Inc, St. Petersburg

33952

MEDSOL Clinical Research, Port Charlotte

34239

Sarasota Memory Hospital Clinical Research Ctr., Sarasota

44106

Parkinson's & Movement Disorders Center, UH Cleveland Medical Center, Cleveland

45212

Riverhills Healthcare, Inc., Cincinnati

48334

Quest Research Institute, Farmington Hills

80113

Rocky Mountain Movement Disorders Center, PC, Englewood

90033

Keck Hospital of University of Southern California, Los Angeles

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Enterin Inc.

INDUSTRY