Tenapanor in Synucleinopathy-Related Constipation

February 6, 2025 updated by: Cedar Valley Digestive Health Center

Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation

Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Randomized, double-blind, placebo controlled trial of tenapanor vs. placebo for treating synucleinopathy-associated constipation in Parkinson's disease.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Richard A. Manfready, MD, AM, FACP
  • Phone Number: (319) 235-5390
  • Email: rman@alum.mit.edu

Study Contact Backup

Study Locations

  • United States
    • Iowa
      • Waterloo, Iowa, United States, 50701
        • Recruiting
        • Cedar Valley Digestive Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Age 50-89 years.
  2. Diagnosis of PD within Hoehn and Yahr stages 1-3, confirmed by a neurologist per International Parkinson and Movement Disorder Society criteria.
  3. 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.
  4. Stool consistency ≤3 on the Bristol Stool Form Scale (BSFS). This criterion will be verified during a 2-week screening period.
  5. Agreement to use contraception, if applicable.

Exclusion Criteria

  1. Functional diarrhea or IBS-D/M based on Rome IV Criteria.
  2. Symptomatic structural GI abnormalities or inflammatory bowel disease.
  3. Significant hepatic (ALT or AST ≥ 2.5x the upper limit of normal) or renal (serum creatinine >2mg/dl) dysfunction.
  4. Pregnancy or lactation.
  5. Diagnosis of primary dyssynergic defecation by anorectal manometry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo orally twice daily for 12 weeks
Drug: Placebo
Placebo drug
Experimental: Tenapanor
Tenapanor 50 mg orally twice daily for 12 weeks
Drug: Tenapanor
Inhibitor of NHE3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 of 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calprotectin
Time Frame: Week 12
Decrease in fecal calprotectin by 20% or greater
Week 12
Abdominal pain and bloating response
Time Frame: 6 of 12 weeks
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)
6 of 12 weeks
Lipopolysaccharide binding protein
Time Frame: Week 12
Decrease in serum lipopolysaccharide binding protein by 20% compared to baseline
Week 12
Complete spontaneous bowel movements (CSBM) continuous
Time Frame: Week 12
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
Week 12
Plasma zonulin
Time Frame: Week 12
Decrease in zonulin by 20% compared to baseline
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedar Valley Digestive Health Center

Collaborators

Ardelyx

Investigators

  • Principal Investigator: Richard A. Manfready, MD, AM, FACP, Cedar Valley Digestive Health Center
  • Study Chair: Ravindra Mallavarapu, MD, Cedar Valley Digestive Health Center
  • Study Director: Harichandana Punukula, PharmD, MS, Cedar Valley Digestive Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2405-21279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant data

IPD Sharing Time Frame

Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 24 months. Data will be available upon request for 2 years following study publication.

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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