Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related Constipation
RASMET
A Multi-Center, Single-Dose, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Related Constipation
1 other identifier
interventional
50
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2017
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2017
CompletedFirst Posted
Study publicly available on registry
February 9, 2017
CompletedStudy Start
First participant enrolled
May 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2018
CompletedResults Posted
Study results publicly available
November 30, 2023
CompletedDecember 27, 2023
December 1, 2023
12 months
February 3, 2017
September 21, 2023
December 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events.
Specific treatment related events of recurrent vomiting, recurrent diarrhea, abdominal pain, and hypotension will be assessed with respect to grade and frequency of occurrence.
Through study completion, up to 11 weeks
Secondary Outcomes (1)
Frequency of Bowel Movements
Through study completion, up to 11 weeks
Study Arms (2)
ENT-01
EXPERIMENTALENT-01 at a to-be-determined dose taken by mouth every day upon awakening.
Placebo Comparator
PLACEBO COMPARATORPlacebo to be taken by mouth every day upon awakening
Interventions
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.
Eligibility Criteria
You may qualify if:
- Parkinson's disease diagnosis confirmed by a neurologist specializing in movement disorders
- Insufficient criteria for a diagnosis of Irritable Bowel Syndrome
- Constipation for over 6 months, unresponsive to Milk of Magnesia, and requiring at least weekly treatment using an oral laxative, stool softener, bulking agent, and/or a suppository, and dissatisfaction with current treatment.
- Body Mass Index is 18-40 kg/m2
- At least 2 of the Rome IV functional constipation criteria are met
- Loose stools are rarely present without the use of laxatives
- Patient is willing and able to sign informed consent and comply with all study procedures
- Patients must be able to read, understand, and accurately record data into the diary to guarantee full participation in the study
- Females only:
- Must have negative serum or urine pregnancy tests and must not be lactating
- If of child-bearing age: Must agree to using a hormonal (i.e., oral, implantable, or injectable) and either single- or double-barrier method of birth control throughout the study period. A vasectomized partner will be allowed as one in conjunction with another single-barrier method.
- If unable to have children: Must have this documented in the case report form (i.e., ubal ligation, hysterectomy, or post-menopausal \[defined as a minimum of one year since last menstrual period\]). Post-menopausal status will be confirmed by follicle stimulating hormone in women less than 60 years of age.
You may not qualify if:
- Unable or unwilling to provide informed consent or to comply with study procedures
- Diagnosis of secondary constipation beyond that of PD
- Structural or metabolic diseases that affect the GI system
- Functional GI disorder
- Unable or unwilling to withdraw from taking the following medications 2 weeks prior to the dose-escalation period and throughout the study: Laxatives, opiates, sedatives, hypnotics, anti-histamines, protein pump inhibitors or any medications which may cause constipation
- History of recent major surgery (within 60 days of screening)
- Any clinically significant abnormalities on screening laboratories or physical examination as determined by the Investigator
- Neurological disorder other than PD
- On treatment with intra-jejunal dopamine
- Treatment with COMT inhibitors for fewer than 4 weeks (entacapone, tolcapone, Stalevo)
- Unable to maintain a stable diet regimen
- Patients with a cognitive impairment that preclude them from understanding the informed consent
- Patients placed under legal guardianship
- Acute GI illness within 48 hours of the baseline period
- History of major GI surgery (e.g. previous abdominal surgery, including cholecystectomy), except that patients with uncomplicated appendectomy are allowed
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Enterin Inc.lead
Study Sites (15)
Keck Hospital of University of Southern California
Los Angeles, California, 90033, United States
Rocky Mountain Movement Disorders Center, PC
Englewood, Colorado, 80113, United States
Georgetown Universtiy, Department of Neurology
Washington D.C., District of Columbia, 20007, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486, United States
Neuroscience Research, University of Florida Jacksonville
Jacksonville, Florida, 32209, United States
MEDSOL Clinical Research
Port Charlotte, Florida, 33952, United States
Sarasota Memory Hospital Clinical Research Ctr.
Sarasota, Florida, 34239, United States
Suncoast Neuroscience Associates, Inc
St. Petersburg, Florida, 33713, United States
USF Health Byrd Parkinson's Disease Movement Disorders Center of Excellence
Tampa, Florida, 33613, United States
Quest Research Institute
Farmington Hills, Michigan, 48334, United States
Movement Disorders Division, Mt. Sinai School of Medicine
New York, New York, 10029, United States
Riverhills Healthcare, Inc.
Cincinnati, Ohio, 45212, United States
Parkinson's & Movement Disorders Center, UH Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Penn State Health, Department of Neurology
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University, Department of Neurology
Philadelphia, Pennsylvania, 19107, United States
Related Publications (1)
Hauser RA, Sutherland D, Madrid JA, Rol MA, Frucht S, Isaacson S, Pagan F, Maddux BN, Li G, Tse W, Walter BL, Kumar R, Kremens D, Lew MF, Ellenbogen A, Oguh O, Vasquez A, Kinney W, Lowery M, Resnick M, Huff N, Posner J, Ballman KV, Harvey BE, Camilleri M, Zasloff M, Barbut D. Targeting neurons in the gastrointestinal tract to treat Parkinson's disease. Clin Park Relat Disord. 2019 Jul 2;1:2-7. doi: 10.1016/j.prdoa.2019.06.001. eCollection 2019.
PMID: 34316590RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Richard Larson, Chief Medical Officer
- Organization
- Enterin
Study Officials
- STUDY CHAIR
Denise Barbut, MD FRCP
Enterin Inc.
- PRINCIPAL INVESTIGATOR
Steven Frucht, MD
NYU Langone Health
- PRINCIPAL INVESTIGATOR
Robert Hauser, MD MBA
University of South Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2017
First Posted
February 9, 2017
Study Start
May 11, 2017
Primary Completion
April 25, 2018
Study Completion
June 14, 2018
Last Updated
December 27, 2023
Results First Posted
November 30, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share
Anonymized data may be shared with other clinical researchers outside of this study that are involved in similar research at non-participating institutions.