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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Parkinson's Disease, Constipation

In brief

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.

Key facts

Study ID

NCT03047629

Run by

Enterin Inc.

People needed

50

Starts

2017-05-11

Expected to finish

2018-06-14

Last updated by the study team

2023-12-27

Who can join

Age: 30 and older, up to 86. Sex: any. Healthy volunteers: not accepted.

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
• ALT or AST > 1.5 X upper limit of normal (ULN) during screening
• Females who are pregnant or breastfeeding
• History of excessive alcohol use or substance abuse
• Patient or caregiver unable to administer daily oral dosing
• Participation in an investigational clinical study within the 6 months prior to dosing in the present study
• Any other reason, which in the opinion of the Investigator would confound proper interpretation of the study

Where it is running

• 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

Full record on ClinicalTrials.gov

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