Parkinson DiseasePhase 2RolloverNCT04483479
Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety "Roll-over" Study (Rollover)
A Phase 2 study testing Active Investigational Treatment ENT-01 in people with Parkinson Disease and Constipation, run by Enterin Inc. at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Parkinson Disease, Constipation
- What is being tested?
- Active Investigational Treatment ENT-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 18 sitesUnited States
- Study dates
- 30 Jul 2020to 17 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Acute GI illness within 2 weeks of the screening visit.
- History of major GI surgery within 30 days of the screening visit (a history of cholecystectomy, polypectomy, hernia repair or appendicectomy are not exclusionary as long as they were performed more than 30 days before 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.
- Females who are pregnant or breastfeeding.
- Subject or caregiver unable to administer daily oral dosing of study drug.
- Participation in a non-Enterin investigational drug trial within the month prior to dosing in the present study.
- Any other reason, which in the opinion of the investigator would confound proper interpretation of the study.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Albany Medical College
Albany, New York, 12208
JEM Research Institute
Atlantis, Florida, 33462
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Cleveland Clinic
Cleveland, Ohio, 44095
Rocky Mountain Movement Disorders Center
Englewood, Colorado, 80113
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, 92708
Penn State University
Hershey, Pennsylvania, 17033
University Physicians & Surgeons, Inc. dba Marshall Health
Huntington, West Virginia, 25701
Evergreen Health - Booth Gardner Parkinson's Care Center
Kirkland, Washington, 98034
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 13756
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
SC3 Research - Pasadena
Pasadena, California, 91105
Parkinson's Disease Treatment Center of SWFL
Port Charlotte, Florida, 33980
Intercoastal Medical Group
Sarasota, Florida, 34239
USF Health Byrd Parkinson's Disease Movement Disorders Center of Excellence
Tampa, Florida, 33613
University of Toledo Medical Center
Toledo, Ohio, 43614
Georgetown Universtiy, Department of Neurology
Washington D.C., District of Columbia, 20007
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407
About this study
Official title: A Multicenter, Non-Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered ENT-01 in Improving Constipation and Neurologic Symptoms in Patients With Parkinson's Disease and Constipation Over a 14-week Period
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.
Read the detailed description
The study will be conducted on an out-patient or in-patient basis with visits performed at the screening visit, at 6 and 12 weeks, and at the end of the 6th week of the wash-out period (end of study).
The dose escalation period will last up to 20 days, the fixed dose period will last 12 weeks, and the wash-out period will last 6 weeks.
Subjects will begin dosing at the same dose level they were stratified to in the ENT-01-030 randomized study (i.e., starting at either 3 tablets or 6 tablets,) and escalate up to a pro-kinetic dose or a maximum dose of 250mg.
- Conditions
- Parkinson Disease, Constipation
- Being tested
- Active Investigational Treatment ENT-01
- Medical subject headings
- Parkinson Disease, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Investigational Treatment ENT-01Drug
Also called ENT-01
ENT-01 will be administered in tablet form, once daily in escalating doses followed by a fixed-dose for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Orally Administered ENT-01 25mg Tablet Once Daily (Dose dependent on ENT-01-030 dose level stratification) Receives: Drug: Active Investigational Treatment ENT-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Related Adverse Events
Number of participants with Treatment Related Adverse Events
Measured: 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
Measured: 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
Measured: 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
Measured: Through study treatment and completion up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start30 Jul 2020
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Why it stopped: Poor recruitment/retention due to the pandemic. Data was not analyzed due to early termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a Phase 2b, non-randomized, open-label study.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enterin Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Zasloff, MD, PhD, Study chair, Enterin Inc.Denise Barbut, MD, FRCP, Study director, Enterin Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483479
- Sponsor's protocol ID
- ENT-01-2b-20-02
- Acronym
- Rollover
- Status last verified
- Feb 2024
- First submitted
- 20 Jul 2020
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered ENT-01 in Improving Constipation and Neurologic Symptoms in Patients With Parkinson's Disease and Constipation Over a 14-week Period
- ClinicalTrials.gov ID
- NCT04483479
- Acronym / sponsor ID
- Rollover / ENT-01-2b-20-02
- Conditions
- Parkinson Disease, Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment/retention due to the pandemic. Data was not analyzed due to early termination.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Enterin Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Posted 19 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be conducted on an out-patient or in-patient basis with visits performed at the screening visit, at 6 and 12 weeks, and at the end of the 6th week of the wash-out period (end of study).
The dose escalation period will last up to 20 days, the fixed dose period will last 12 weeks, and the wash-out period will last 6 weeks.
Subjects will begin dosing at the same dose level they were stratified to in the ENT-01-030 randomized study (i.e., starting at either 3 tablets or 6 tablets,) and escalate up to a pro-kinetic dose or a maximum dose of 250mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a Phase 2b, non-randomized, open-label study.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Drug: Active Investigational Treatment ENT-01Orally Administered ENT-01 25mg Tablet Once Daily (Dose dependent on ENT-01-030 dose level stratification) |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Investigational Treatment ENT-01Also: ENT-01ENT-01 will be administered in tablet form, once daily in escalating doses followed by a fixed-dose for 12 weeks. | Drug | Active Treatment |
Primary outcome
Number of Participants With Treatment Related Adverse Events
Time frame: Through study treatment and completion up to 14 weeks
Number of participants with Treatment Related Adverse Events
Number of Participants With Treatment Related Recurrent Vomiting
Time frame: Through study treatment and completion up to 14 weeks
The number of participants with treatment related episodes of recurrent vomiting defined as 3-5 episodes of vomiting within 24 hours
Number of Participants With Treatment Related Recurrent Diarrhea
Time frame: Through study treatment and completion up to 14 weeks
The number of participants with treatment related episodes of recurrent diarrhea defined as 7 episodes of diarrhea within 24 hours for 2 consecutive days
Number of Participants With Treatment Related Dizziness
Time frame: Through study treatment and completion up to 14 weeks
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Zasloff, MD, PhD study chair
Enterin Inc.
Denise Barbut, MD, FRCP study director
Enterin Inc.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active Investigational Treatment ENT-01 in people with Parkinson Disease and Constipation, run by Enterin Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Related Adverse Events (time frame: Through study treatment and completion up to 14 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.