SynucleinopathyPhase 2NCT06460038
Tenapanor in Synucleinopathy-Related Constipation
A Phase 2 study testing Tenapanor in people with Synucleinopathy and Parkinson's Disease, run by Cedar Valley Digestive Health Center at 1 site in United States.
Trial summary
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Synucleinopathy, Parkinson's Disease
- What is being tested?
- Tenapanor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 50 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-89 years.
- Diagnosis of PD within Hoehn and Yahr stages 1-3, confirmed by a neurologist per International Parkinson and Movement Disorder Society criteria.
- Average weekly stool frequency of ≤5 spontaneous bowel movements (SBMs) and ≤2 complete spontaneous bowel movements (CSBMs) over the past 6 months. These criteria will be verified during a 2-week screening period.
- Stool consistency ≤3 on the Bristol Stool Form Scale (BSFS). This criterion will be verified during a 2-week screening period.
- Agreement to use contraception, if applicable.
Who cannot join
- Functional diarrhea or IBS-D/M based on Rome IV Criteria.
- Symptomatic structural GI abnormalities or inflammatory bowel disease.
- Significant hepatic (ALT or AST ≥ 2.5x the upper limit of normal) or renal (serum creatinine >2mg/dl) dysfunction.
- Pregnancy or lactation.
- Diagnosis of primary dyssynergic defecation by anorectal manometry.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedar Valley Digestive Health Center
Waterloo, Iowa, 50701
Harichandana Punukula, PharmD, MS, 319-888-8275, hpunukula@cvmspc.com
About this study
Official title: Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation
Read the detailed description
Randomized, double-blind, placebo controlled trial of tenapanor vs. placebo for treating synucleinopathy-associated constipation in Parkinson\'s disease.
- Conditions
- Synucleinopathy, Parkinson's Disease
- Being tested
- Tenapanor, Placebo
- Keywords
- tenapanor, synucleinopathy, Parkinson's disease, constipation
- Medical subject headings
- Synucleinopathies, Parkinson Disease, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenapanorDrug
Inhibitor of NHE3
PlaceboDrug
Placebo drug
| Study group | Role | What they receive |
|---|---|---|
| Tenapanor | Experimental | Tenapanor 50 mg orally twice daily for 12 weeks Receives: Drug: Tenapanor |
| Placebo | Placebo comparator | Placebo orally twice daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete spontaneous bowel movements (CSBM)
Our primary endpoint will be CSBM response, defined as an increase of at least one CSBM per week compared to baseline for at least 6 of the 12 treatment weeks. A CSBM is defined as a bowel movement that occurs naturally and is accompanied by a feeling of complete evacuation
Measured: 6 of 12 weeks
Secondary outcomes (5)
Abdominal pain and bloating response
Decrease in severity score of at least 20% or more from baseline in 6 of 12 weeks (pain visual analog scale 1-10 where 10 is worst pain)
Measured: 6 of 12 weeks
Calprotectin
Decrease in fecal calprotectin by 20% or greater
Measured: Week 12
Lipopolysaccharide binding protein
Decrease in serum lipopolysaccharide binding protein by 20% compared to baseline
Measured: Week 12
Complete spontaneous bowel movements (CSBM) continuous
CSBM treated as a continuous variable. The investigators expect an increase of CSBMs in the treatment group compared to the placebo group. A CSBM is defined as a bowel movement that occurs naturally and is accompanied by a feeling of complete evacuation
Measured: Week 12
Plasma zonulin
Decrease in zonulin by 20% compared to baseline
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SynucleinopathyStudies 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
- Model description
- Randomized, double-blind, placebo controlled trial of tenapanor vs. placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedar Valley Digestive Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ardelyx
- Responsible party
- Sponsor
- Investigators
- Richard A. Manfready, MD, AM, FACP, Principal investigator, Cedar Valley Digestive Health CenterRavindra Mallavarapu, MD, Study chair, Cedar Valley Digestive Health CenterHarichandana Punukula, PharmD, MS, Study director, Cedar Valley Digestive Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460038
- Sponsor's protocol ID
- 2405-21279
- Status last verified
- Feb 2025
- First submitted
- 11 Jun 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data
Publications
Manfready RA, Engen PA, Verhagen Metman L, Sanzo G, Goetz CG, Hall DA, Forsyth CB, Raeisi S, Voigt RM, Keshavarzian A. Attenuated Postprandial GLP-1 Response in Parkinson's Disease. Front Neurosci. 2021 Jul 2;15:660942. doi: 10.3389/fnins.2021.660942. eCollection 2021.
PubMed 34276285Manfready RA, Forsyth CB, Voigt RM, Hall DA, Goetz CG, Keshavarzian A. Gut-Brain Communication in Parkinson's Disease: Enteroendocrine Regulation by GLP-1. Curr Neurol Neurosci Rep. 2022 Jul;22(7):335-342. doi: 10.1007/s11910-022-01196-5. Epub 2022 May 28.
PubMed 35633466Post Z, Manfready RA, Keshavarzian A. Overview of the Gut-Brain Axis: From Gut to Brain and Back Again. Semin Neurol. 2023 Aug;43(4):506-517. doi: 10.1055/s-0043-1771464. Epub 2023 Aug 10.
PubMed 37562457Hall DA, Voigt RM, Cantu-Jungles TM, Hamaker B, Engen PA, Shaikh M, Raeisi S, Green SJ, Naqib A, Forsyth CB, Chen T, Manfready R, Ouyang B, Rasmussen HE, Sedghi S, Goetz CG, Keshavarzian A. An open label, non-randomized study assessing a prebiotic fiber intervention in a small cohort of Parkinson's disease participants. Nat Commun. 2023 Feb 18;14(1):926. doi: 10.1038/s41467-023-36497-x.
PubMed 36801916Chey WD, Lembo AJ, Rosenbaum DP. Tenapanor Treatment of Patients With Constipation-Predominant Irritable Bowel Syndrome: A Phase 2, Randomized, Placebo-Controlled Efficacy and Safety Trial. Am J Gastroenterol. 2017 May;112(5):763-774. doi: 10.1038/ajg.2017.41. Epub 2017 Feb 28.
PubMed 28244495Chey WD, Lembo AJ, Yang Y, Rosenbaum DP. Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2). Am J Gastroenterol. 2021 Jun 1;116(6):1294-1303. doi: 10.14309/ajg.0000000000001056.
PubMed 33337659Chey WD, Lembo AJ, Rosenbaum DP. Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1). Am J Gastroenterol. 2020 Feb;115(2):281-293. doi: 10.14309/ajg.0000000000000516.
PubMed 31934897
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation
- ClinicalTrials.gov ID
- NCT06460038
- Acronym / sponsor ID
- 2405-21279
- Conditions
- Synucleinopathy, Parkinson's Disease
- Keywords
- tenapanor, synucleinopathy, Parkinson's disease, constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cedar Valley Digestive Health CenterUniversity, hospital or other
- Collaborators
- Ardelyx
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation
Detailed description
Randomized, double-blind, placebo controlled trial of tenapanor vs. placebo for treating synucleinopathy-associated constipation in Parkinson\'s disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo controlled trial of tenapanor vs. placebo
| Arm | Type | Receives |
|---|---|---|
| Tenapanor | Experimental | Drug: TenapanorTenapanor 50 mg orally twice daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo orally twice daily for 12 weeks |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50-89 years.
- Diagnosis of PD within Hoehn and Yahr stages 1-3, confirmed by a neurologist per International Parkinson and Movement Disorder Society criteria.
- Average weekly stool frequency of ≤5 spontaneous bowel movements (SBMs) and ≤2 complete spontaneous bowel movements (CSBMs) over the past 6 months. These criteria will be verified during a 2-week screening period.
- Stool consistency ≤3 on the Bristol Stool Form Scale (BSFS). This criterion will be verified during a 2-week screening period.
- Agreement to use contraception, if applicable.
Key exclusion criteria (5 listed)
- Functional diarrhea or IBS-D/M based on Rome IV Criteria.
- Symptomatic structural GI abnormalities or inflammatory bowel disease.
- Significant hepatic (ALT or AST ≥ 2.5x the upper limit of normal) or renal (serum creatinine >2mg/dl) dysfunction.
- Pregnancy or lactation.
- Diagnosis of primary dyssynergic defecation by anorectal manometry.
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 |
|---|---|---|
| TenapanorInhibitor of NHE3 | Drug | Tenapanor |
| PlaceboPlacebo drug | Drug | Placebo |
Primary outcome
Complete spontaneous bowel movements (CSBM)
Time frame: 6 of 12 weeks
Our primary endpoint will be CSBM response, defined as an increase of at least one CSBM per week compared to baseline for at least 6 of the 12 treatment weeks. A CSBM is defined as a bowel movement that occurs naturally and is accompanied by a feeling of complete evacuation
5 secondary outcomes
Abdominal pain and bloating response
Time frame: 6 of 12 weeks
Calprotectin
Time frame: Week 12
Lipopolysaccharide binding protein
Time frame: Week 12
Complete spontaneous bowel movements (CSBM) continuous
Time frame: Week 12
Plasma zonulin
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Background: PubMed 34276285Manfready RA, Engen PA, Verhagen Metman L, Sanzo G, Goetz CG, Hall DA, Forsyth CB, Raeisi S, Voigt RM, Keshavarzian A. Attenuated Postprandial GLP-1 Response in Parkinson's Disease. Front Neurosci. 2021 Jul 2;15:660942. doi: 10.3389/fnins.2021.660942. eCollection 2021.
- Background: PubMed 35633466Manfready RA, Forsyth CB, Voigt RM, Hall DA, Goetz CG, Keshavarzian A. Gut-Brain Communication in Parkinson's Disease: Enteroendocrine Regulation by GLP-1. Curr Neurol Neurosci Rep. 2022 Jul;22(7):335-342. doi: 10.1007/s11910-022-01196-5. Epub 2022 May 28.
- Background: PubMed 37562457Post Z, Manfready RA, Keshavarzian A. Overview of the Gut-Brain Axis: From Gut to Brain and Back Again. Semin Neurol. 2023 Aug;43(4):506-517. doi: 10.1055/s-0043-1771464. Epub 2023 Aug 10.
- Background: PubMed 36801916Hall DA, Voigt RM, Cantu-Jungles TM, Hamaker B, Engen PA, Shaikh M, Raeisi S, Green SJ, Naqib A, Forsyth CB, Chen T, Manfready R, Ouyang B, Rasmussen HE, Sedghi S, Goetz CG, Keshavarzian A. An open label, non-randomized study assessing a prebiotic fiber intervention in a small cohort of Parkinson's disease participants. Nat Commun. 2023 Feb 18;14(1):926. doi: 10.1038/s41467-023-36497-x.
- Background: PubMed 28244495Chey WD, Lembo AJ, Rosenbaum DP. Tenapanor Treatment of Patients With Constipation-Predominant Irritable Bowel Syndrome: A Phase 2, Randomized, Placebo-Controlled Efficacy and Safety Trial. Am J Gastroenterol. 2017 May;112(5):763-774. doi: 10.1038/ajg.2017.41. Epub 2017 Feb 28.
- Background: PubMed 33337659Chey WD, Lembo AJ, Yang Y, Rosenbaum DP. Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2). Am J Gastroenterol. 2021 Jun 1;116(6):1294-1303. doi: 10.14309/ajg.0000000000001056.
- Background: PubMed 31934897Chey WD, Lembo AJ, Rosenbaum DP. Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1). Am J Gastroenterol. 2020 Feb;115(2):281-293. doi: 10.14309/ajg.0000000000000516.
- Individual participant dataSharing planned: Yes. De-identified participant data
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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.
Richard A. Manfready, MD, AM, FACP principal investigator
Cedar Valley Digestive Health Center
Ravindra Mallavarapu, MD study chair
Cedar Valley Digestive Health Center
Harichandana Punukula, PharmD, MS study director
Cedar Valley Digestive Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tenapanor in people with Synucleinopathy and Parkinson's Disease, run by Cedar Valley Digestive Health Center at 1 site 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard A. Manfready, MD, AM, FACP ((319) 235-5390, rman@alum.mit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete spontaneous bowel movements (CSBM) (time frame: 6 of 12 weeks). 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 NCT06460038, which also lists 7 linked publications.
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 10 Feb 2025.