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Register:	ClinicalTrials.gov
Last refreshed on:	10 July 2023
Main ID:	NCT03047629
Date of registration:	03/02/2017
Prospective Registration:	Yes
Primary sponsor:	Enterin Inc.
Public title:	Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related Constipation RASMET
Scientific title:	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
Date of first enrolment:	May 11, 2017
Target sample size:	50
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03047629
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	Phase 1/Phase 2

Countries of recruitment
United States

Contacts

Name:	Steven Frucht, MD
Address:
Telephone:
Email:
Affiliation:	NYU Langone Health

Name:	Denise Barbut, MD FRCP
Address:
Telephone:
Email:
Affiliation:	Enterin Inc.

Name:	Robert Hauser, MD MBA
Address:
Telephone:
Email:
Affiliation:	University of South Florida

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Parkinson's disease diagnosis confirmed by a neurologist specializing in movement
disorders

2. Insufficient criteria for a diagnosis of Irritable Bowel Syndrome

3. 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.

4. Body Mass Index is 18-40 kg/m2

5. At least 2 of the Rome IV functional constipation criteria are met

6. Loose stools are rarely present without the use of laxatives

7. Patient is willing and able to sign informed consent and comply with all study
procedures

8. Patients must be able to read, understand, and accurately record data into the diary
to guarantee full participation in the study

Females only:

9. Must have negative serum or urine pregnancy tests and must not be lactating

10. 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.

11. 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.

Exclusion Criteria:

1. Unable or unwilling to provide informed consent or to comply with study procedures

2. Diagnosis of secondary constipation beyond that of PD

3. Structural or metabolic diseases that affect the GI system

4. Functional GI disorder

5. 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

6. History of recent major surgery (within 60 days of screening)

7. Any clinically significant abnormalities on screening laboratories or physical
examination as determined by the Investigator

8. Neurological disorder other than PD

9. On treatment with intra-jejunal dopamine

10. Treatment with COMT inhibitors for fewer than 4 weeks (entacapone, tolcapone, Stalevo)

11. Unable to maintain a stable diet regimen

12. Patients with a cognitive impairment that preclude them from understanding the
informed consent

13. Patients placed under legal guardianship

14. Acute GI illness within 48 hours of the baseline period

15. History of major GI surgery (e.g. previous abdominal surgery, including
cholecystectomy), except that patients with uncomplicated appendectomy are allowed

16. ALT or AST > 1.5 X upper limit of normal (ULN) during screening

17. Females who are pregnant or breastfeeding

18. History of excessive alcohol use or substance abuse

19. Patient or caregiver unable to administer daily oral dosing

20. Participation in an investigational clinical study within the 6 months prior to dosing
in the present study

21. Any other reason, which in the opinion of the Investigator would confound proper
interpretation of the study

Age minimum: 30 Years
Age maximum: 86 Years
Gender: All

Health Condition(s) or Problem(s) studied

Constipation

Parkinson's Disease

Intervention(s)

Other: Placebo

Drug: ENT-01

Primary Outcome(s)

Number of participants with treatment-related adverse events as assessed by common terminology criteria for adverse events. [Time Frame: Through study completion, up to 11 weeks]

Secondary Outcome(s)

Frequency of bowel movements [Time Frame: Through study completion, up to 11 weeks]

Secondary ID(s)

ENT-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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