ConstipationPhase 2KARMETNCT03781791
Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET)
A Phase 2 study testing Active Investigational Treatment ENT-01 in people with Constipation and Parkinson Disease, run by Enterin Inc. at 51 sites in United States.
Trial summary
This study will be conducted as a multi-center, randomized, double-blind, placebo-controlled study. Approximately 72 patients will be randomized 3:1 to treatment or placebo, with approximately 54 patients allocated to receive the active investigational product and approximately 18 patients allocated to receive… Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Constipation, Parkinson Disease
- What is being tested?
- Active Investigational Treatment ENT-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 51 sitesUnited States
- Study dates
- 10 Dec 2018to 14 Dec 2021
- 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
- Subjects aged 30-90 years, both genders
- Subjects must provide written informed consent and be willing and able to comply with study procedures.
- Subjects must be diagnosed with Parkinson's Disease defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features: rest tremor, rigidity, bradykinesia and/or akinesia, postural and gait abnormalities.
- There are insufficient criteria for Irritable Bowel Syndrome (IBS)
- Constipation which has been present for over 6 months and is unresponsive to first line, typically over the counter treatments such as Milk of Magnesia (1g), Miralax (17g in 8 ounces of water) or the equivalent at least once weekly with an inconsistent response over a 6-week period or the subject is dissatisfied with first line treatments.
- Body mass index (BMI) of 18-40 kg/m2
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- Subjects must fulfill Rome IV criteria for functional constipation which includes 2 or more of the following:
- Straining during at least 25% of defecations
- Lumpy or hard stools in at least 25% of defecations
- Sensation of incomplete evacuation for at least 25% of defecations
- Sensation of anorectal obstruction/blockage for at least 25% of defecations
- Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
- Self-report of fewer than 3 complete spontaneous bowel movements per week
- Loose stools are rarely present without the use of laxatives
- 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.
- Diagnosis of secondary constipation beyond that of Parkinson's Disease
- Review of Screening Diaries indicates fewer than 11 days of diary completion and/or 3 or more complete spontaneous bowel movements (CSBM) per week based upon the average CSBM rate reported during the Screening Period
- A compromised gastrointestinal system which includes:
- Structural, metabolic, or functional GI diseases or disorders
- Acute GI illness within 2 weeks of the screening visit
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- 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)
- 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.
- Unable or unwilling to withdraw from proton pump inhibitors and antacids at the end of the screening period.
- Unable or unwilling to withdraw from pimavanserin during the study.
- Any clinically significant abnormalities on screening laboratories or physical examination requiring further evaluation or treatment.
- 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.
- Females who are pregnant or breastfeeding.
- History of excessive alcohol use or substance abuse.
- Participation in an 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
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Albany Medical College
Albany, New York, 12208
Interspond - The Neuromedical Clinic of Central Louisiana
Alexandria, Louisiana, 71301
BTC Network - Community Clinical Research Center
Anderson, Indiana, 46011
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
JEM Research Institute
Atlantis, Florida, 33462
The NeuroMedical Center, P.C.
Baton Rouge, Louisiana, 70810
North Texas Movement Disorders Institute
Bedford, Texas, 76021
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459
University of Cincinnati
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44095
BTC Network - Neurological Associates of North Texas
Dallas, Texas, 75218
Elias Research - Neurology Diagnostics Research
Dayton, Ohio, 45459
Parkinson's and Movement Disorders Center of Maryland
Elkridge, Maryland, 21075
Rocky Mountain Movement Disorders Center
Englewood, Colorado, 80113
Associated Neurologist of Southern CT
Fairfield, Connecticut, 06824
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, 92708
Neuro Pain Medical Center
Fresno, California, 93710
Interspond - Premier Neurology
Greer, South Carolina, 29650
Penn State University
Hershey, Pennsylvania, 17033
Clinical Trial Network
Houston, Texas, 77074
University Physicians & Surgeons, Inc. dba Marshall Health
Huntington, West Virginia, 25701
Evergreen Health - Booth Gardner Parkinson's Care Center
Kirkland, Washington, 98034
Interspond - Neurology Center of Las Vegas
Las Vegas, Nevada, 89128
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 13756
Neurology Associates Clinical Research
Lincoln, Nebraska, 68506
Clinical Trials, Inc.
Little Rock, Arkansas, 72205
Elias Research - Floridian Research Institute
Miami, Florida, 33145
Elias Research - Allied Biomedical Research Institute
Miami, Florida, 33155
Pharmax Research of South Florida
Miami, Florida, 33175
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Sentara Neuroscience Institute
Norfolk, Virginia, 23456
Care Access Research, Norwich
Norwich, Connecticut, 06360
Interspond - Metrolina Neurological Associates
Old Point Station, South Carolina, 29707
Pacific Neuroscience Medical Group
Oxnard, California, 93030
SC3 Research - Pasadena
Pasadena, California, 91105
MEDSOL Clinical Research
Port Charlotte, Florida, 33952
Parkinson's Disease Treatment Center of SWFL
Port Charlotte, Florida, 33980
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
Trial Connections - Care Access Research, Santa Clarita
Santa Clarita, California, 91321
Intercoastal Medical Group
Sarasota, Florida, 34239
Banner Sun Health Research Institute
Sun City, Arizona, 85351
University of South Florida
Tampa, Florida, 33603
University of Toledo Medical Center
Toledo, Ohio, 43614
Evolution Research Group - Neuroscience Research Institution
Toms River, New Jersey, 08755
Neuroscience Researc Institute of NJ
Toms River, New Jersey, 08755
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, 74136
Wake Forest Baptist Medical Center
Wake Forest, North Carolina, 27157
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Palm Beach Neurology and Premier Research Institute
West Palm Beach, Florida, 33407
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease-Related Constipation (KARMET)
This study will be conducted as a multi-center, randomized, double-blind, placebo-controlled study. Approximately 72 patients will be randomized 3:1 to treatment or placebo, with approximately 54 patients allocated to receive the active investigational product and approximately 18 patients allocated to receive placebo.
- Study Update-
Amendment 3 - In this amendment, an additional 80 patients (approximately) will be randomized 1:1 to treatment or placebo (double-blind) with approximately 40 subjects allocated to each group.
Read the detailed description
The study will be conducted on an out-patient basis. Each patient will have 6 visits to the clinic: a screening visit, a randomization visit, 3 follow up visits, and 1 end of study visit.
Patient randomization will be stratified based upon the baseline weekly complete spontaneous bowel movement rate (CSBM) established during the screening period. Patients will be allowed to adjust their dosing, based upon protocol specifications. Rescue medications will be provided to all patients to ensure they move their bowels on a regular basis.
Patients will also be asked to participate in up to 2 sub-studies: a pk study and/or a stool microbiome study. The first 20 patients to consent to the pk study will have additional blood samples taken at randomization and at 2 follow up visits. The first 20 patients to consent to the stool microbiome study will provide stool samples at randomization and at 2 follow up visits.
- Conditions
- Constipation, Parkinson Disease
- Being tested
- Active Investigational Treatment ENT-01, Placebo Treatment
- Medical subject headings
- Constipation, Parkinson Disease
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.
Placebo TreatmentDrug
Placebo will be administered in tablet form, once daily.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | ENT-01 tablet will be taken once daily by mouth. Receives: Drug: Active Investigational Treatment ENT-01 |
| Placebo Treatment | Placebo comparator | Placebo tablet will be taken once daily by mouth. Receives: Drug: Placebo Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Who Experience Treatment Related Adverse Events-Safety Endpoint
The number of treatment related adverse events as reported and assessed by NCI CTCAE v.4.3.
Measured: Through Study treatment up to 10 weeks
The Number of Participants Who Experience Dose Limiting Toxicity Adverse Events
The number of participants who experience dose limiting toxicity adverse events as reported and assessed by NCI CTCAE v.4.3.
Per protocol, dose limiting toxicity adverse events are vomiting, diarrhea, abdominal pain and dizziness.
Measured: Through Study treatment Dosing Period up to 10 weeks
Change in Baseline Weekly CSBM-Primary Efficacy Endpoint
Change from participant's weekly CSBM baseline rate during treatment fixed Dose period.
The fixed dose period begins on the first day or the subject's highest dose at which the subject did not experience a dose limiting toxicity (nausea, vomiting, diarrhea or dizziness) The fixed dose period will not be a specific time period for all subjects since each subject will start the fixed dose period based on their tolerability to ENT-01 dosing.
Measured: 25 day treatment period, part of which is at a fixed dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start10 Dec 2018
- Primary completion14 Dec 2021
- Study completion14 Dec 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 151 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
- NCT03781791
- Sponsor's protocol ID
- ENT-01-030
- Acronym
- KARMET
- Status last verified
- Jan 2024
- First submitted
- 27 Nov 2018
- Last updated
- 20 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Camilleri M, Subramanian T, Pagan F, Isaacson S, Gil R, Hauser RA, Feldman M, Goldstein M, Kumar R, Truong D, Chhabria N, Walter BL, Eskenazi J, Riesenberg R, Burdick D, Tse W, Molho E, Robottom B, Bhatia P, Kadimi S, Klos K, Shprecher D, Marquez-Mendoza O, Hidalgo G, Grill S, Li G, Mandell H, Hughes M, Stephenson S, Vandersluis J, Pfeffer M, Duker A, Shivkumar V, Kinney W, MacDougall J, Zasloff M, Barbut D. Oral ENT-01 Targets Enteric Neurons to Treat Constipation in Parkinson Disease : A Randomized Controlled Trial. Ann Intern Med. 2022 Dec;175(12):1666-1674. doi: 10.7326/M22-1438. Epub 2022 Nov 8.
PubMed 36343348
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease-Related Constipation (KARMET)
- ClinicalTrials.gov ID
- NCT03781791
- Acronym / sponsor ID
- KARMET / ENT-01-030
- Conditions
- Constipation, Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Enterin Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Posted 4 Dec 2023
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 a multi-center, randomized, double-blind, placebo-controlled study. Approximately 72 patients will be randomized 3:1 to treatment or placebo, with approximately 54 patients allocated to receive the active investigational product and approximately 18 patients allocated to receive placebo.
- Study Update-
Amendment 3 - In this amendment, an additional 80 patients (approximately) will be randomized 1:1 to treatment or placebo (double-blind) with approximately 40 subjects allocated to each group.
Detailed description
The study will be conducted on an out-patient basis. Each patient will have 6 visits to the clinic: a screening visit, a randomization visit, 3 follow up visits, and 1 end of study visit.
Patient randomization will be stratified based upon the baseline weekly complete spontaneous bowel movement rate (CSBM) established during the screening period. Patients will be allowed to adjust their dosing, based upon protocol specifications. Rescue medications will be provided to all patients to ensure they move their bowels on a regular basis.
Patients will also be asked to participate in up to 2 sub-studies: a pk study and/or a stool microbiome study. The first 20 patients to consent to the pk study will have additional blood samples taken at randomization and at 2 follow up visits. The first 20 patients to consent to the stool microbiome study will provide stool samples at randomization and at 2 follow up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Drug: Active Investigational Treatment ENT-01ENT-01 tablet will be taken once daily by mouth. |
| Placebo Treatment | Placebo comparator | Drug: Placebo TreatmentPlacebo tablet will be taken once daily by mouth. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects aged 30-90 years, both genders
- Subjects must provide written informed consent and be willing and able to comply with study procedures.
- Subjects must be diagnosed with Parkinson's Disease defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features: rest tremor, rigidity, bradykinesia and/or akinesia, postural and gait abnormalities.
- There are insufficient criteria for Irritable Bowel Syndrome (IBS)
- Constipation which has been present for over 6 months and is unresponsive to first line, typically over the counter treatments such as Milk of Magnesia (1g), Miralax (17g in 8 ounces of water) or the equivalent at least once weekly with an inconsistent response over a 6-week period or the subject is dissatisfied with first line treatments.
Key exclusion criteria (21 listed)
- Unable or unwilling to provide informed consent or to comply with study procedures.
- Diagnosis of secondary constipation beyond that of Parkinson's Disease
- Review of Screening Diaries indicates fewer than 11 days of diary completion and/or 3 or more complete spontaneous bowel movements (CSBM) per week based upon the average CSBM rate reported during the Screening Period
- A compromised gastrointestinal system which includes:
- 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.
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. | Drug | Active Treatment |
| Placebo TreatmentPlacebo will be administered in tablet form, once daily. | Drug | Placebo Treatment |
Primary outcome
The Number of Participants Who Experience Treatment Related Adverse Events-Safety Endpoint
Time frame: Through Study treatment up to 10 weeks
The number of treatment related adverse events as reported and assessed by NCI CTCAE v.4.3.
The Number of Participants Who Experience Dose Limiting Toxicity Adverse Events
Time frame: Through Study treatment Dosing Period up to 10 weeks
The number of participants who experience dose limiting toxicity adverse events as reported and assessed by NCI CTCAE v.4.3. Per protocol, dose limiting toxicity adverse events are vomiting, diarrhea, abdominal pain and dizziness.
Change in Baseline Weekly CSBM-Primary Efficacy Endpoint
Time frame: 25 day treatment period, part of which is at a fixed dose.
Change from participant's weekly CSBM baseline rate during treatment fixed Dose period. The fixed dose period begins on the first day or the subject's highest dose at which the subject did not experience a dose limiting toxicity (nausea, vomiting, diarrhea or dizziness) The fixed dose period will not be a specific time period for all subjects since each subject will start the fixed dose period based on their tolerability to ENT-01 dosing.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36343348Camilleri M, Subramanian T, Pagan F, Isaacson S, Gil R, Hauser RA, Feldman M, Goldstein M, Kumar R, Truong D, Chhabria N, Walter BL, Eskenazi J, Riesenberg R, Burdick D, Tse W, Molho E, Robottom B, Bhatia P, Kadimi S, Klos K, Shprecher D, Marquez-Mendoza O, Hidalgo G, Grill S, Li G, Mandell H, Hughes M, Stephenson S, Vandersluis J, Pfeffer M, Duker A, Shivkumar V, Kinney W, MacDougall J, Zasloff M, Barbut D. Oral ENT-01 Targets Enteric Neurons to Treat Constipation in Parkinson Disease : A Randomized Controlled Trial. Ann Intern Med. 2022 Dec;175(12):1666-1674. doi: 10.7326/M22-1438. Epub 2022 Nov 8.
- 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.
51 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 Constipation and Parkinson Disease, run by Enterin Inc. at 51 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 17 inclusion and 21 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: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 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. Some participants in this study may receive a placebo. 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 4 Dec 2023). 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?
The Number of Participants Who Experience Treatment Related Adverse Events-Safety Endpoint (time frame: Through Study treatment up to 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03781791, which also lists 1 linked publication.
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 20 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.