Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety "Roll-over" Study (Rollover)

NCT04483479 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: ENT-01-2b-20-02
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 18

Brief Summary

This study will be conducted as an open-label safety follow-on to a multi-center, double-blind, randomized study. All subjects who participated in the randomized study will be offered participation in this unblinded, single-arm, safety study. Approximately 50 subjects will be entered into the study and ENT-01 will be administered daily in escalating doses followed by a fixed dose for 12 weeks. Each subject will participate for approximately 20 weeks; dosing duration will be approximately 14 weeks.

Conditions

Parkinson Disease; Constipation

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Treatment Related Adverse Events

  Number of participants with Treatment Related Adverse Events

  Through study treatment and completion up to 14 weeks

• Number of Participants With Treatment Related Recurrent Vomiting

  The number of participants with treatment related episodes of recurrent vomiting defined as 3-5 episodes of vomiting within 24 hours

  Through study treatment and completion up to 14 weeks

• Number of Participants With Treatment Related Recurrent Diarrhea

  The number of participants with treatment related episodes of recurrent diarrhea defined as 7 episodes of diarrhea within 24 hours for 2 consecutive days

  Through study treatment and completion up to 14 weeks

• Number of Participants With Treatment Related Dizziness

  The number of participants with treatment related episodes of dizziness defined as lightheadedness or fainting on rising from lying to sitting or standing and severe enough to require non-urgent medical intervention within 24 hours

  Through study treatment and completion up to 14 weeks

Study Arms (1)

Active Treatment

EXPERIMENTAL

Orally Administered ENT-01 25mg Tablet Once Daily (Dose dependent on ENT-01-030 dose level stratification)

Drug: Active Investigational Treatment ENT-01

Interventions

Active Investigational Treatment ENT-01 DRUG

ENT-01 will be administered in tablet form, once daily in escalating doses followed by a fixed-dose for 12 weeks.

Also known as: ENT-01

Active Treatment

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects who participated in the randomized study ENT-01-030 (KARMET Stage 2 Extension subjects) and who completed the dosing period.
• Subjects aged 30-90 years at the time of screening for the ENT-01-030 study, both genders
• Subjects must provide informed consent and be willing and able to comply with study procedures.
• Subjects must be able to read, understand, and accurately record data into the diary to guarantee full participation in the study.
• Female subjects must have negative serum or urine pregnancy tests and must not be lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. A vasectomized partner will be allowed as one in conjunction with another single-barrier method.
• Female subjects unable to bear children must have this documented in the CRF (i.e., tubal ligation, hysterectomy, or postmenopausal \[defined as a minimum of one year since the last menstrual period\]). Post-menopausal status will be confirmed by follicle stimulating hormone (FSH) 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.
• Unable to withdraw proton pump inhibitors.
• Unable or unwilling to withdraw from laxatives, opiates, clonazepam, or any medications which may cause constipation 2 weeks prior to the dose adjustment period and throughout the rest of the study.
• Diagnosis of secondary constipation beyond that of Parkinson's disease.
• A compromised gastrointestinal system which includes:
• Structural, metabolic, or functional GI diseases or disorders.
• Acute GI illness within 2 weeks of the screening visit.
• Neurological disorder other than Parkinson's disease that in the opinion of the investigator might interfere with the conduct of the study.
• On treatment with intra-jejunal dopamine or carbidopa/levodopa (i.e. Duopa).
• Subjects starting a new Parkinson's disease medication or modifying an existing medication within 2 weeks prior to enrollment.
• Unable to maintain a stable diet regimen.
• Subjects with a cognitive impairment that preclude them from understanding the informed consent.
• Subjects placed under legal guardianship.
• History of excessive alcohol use or substance abuse.
• Any clinically significant abnormalities on screening laboratories or physical examination requiring further evaluation or treatment.

Sponsors & Collaborators

• Enterin Inc.: lead

Study Sites (18)

The Parkinson's and Movement Disorder Institute

Fountain Valley, California, 92708, United States

Location

SC3 Research - Pasadena

Pasadena, California, 91105, United States

Location

Rocky Mountain Movement Disorders Center

Englewood, Colorado, 80113, United States

Location

Georgetown Universtiy, Department of Neurology

Washington D.C., District of Columbia, 20007, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Parkinson's Disease Treatment Center of SWFL

Port Charlotte, Florida, 33980, United States

Location

Intercoastal Medical Group

Sarasota, Florida, 34239, United States

Location

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

Tampa, Florida, 33613, United States

Location

Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, 33407, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 13756, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44095, United States

Location

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

Penn State University

Hershey, Pennsylvania, 17033, United States

Location

Evergreen Health - Booth Gardner Parkinson's Care Center

Kirkland, Washington, 98034, United States

Location

University Physicians & Surgeons, Inc. dba Marshall Health

Huntington, West Virginia, 25701, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Constipation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study was terminated early due to poor recruitment/retention due to the pandemic.

Results Point of Contact

• Title: Dr. Richard Larson, Chief Medical Officer
• Organization: Enterin

r.larson@enterininc.com

5054692670

Study Officials

• Michael Zasloff, MD, PhD

  Enterin Inc.

  STUDY CHAIR

• Denise Barbut, MD, FRCP

  Enterin Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 2b, non-randomized, open-label study.

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: July 30, 2020
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: March 19, 2024
• Results First Posted: March 19, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)