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Tenapanor in Synucleinopathy-Related Constipation | Clinical Trials | Clareo Health

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RECRUITINGPhase 2NCT06460038

Tenapanor in Synucleinopathy-Related Constipation

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

Lead sponsor: Cedar Valley Digestive Health Center•1 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Richard A. Manfready, MD, AM, FACP

CONTACT

(319) 235-5390 rman@alum.mit.edu

Harichandana Punukula, PharmD, MS

CONTACT

319-888-8270 hpunukula@cvmspc.com

Sponsors

Lead Sponsor

Cedar Valley Digestive Health Center

Collaborators

Ardelyx

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

Age

50 - 89 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 10, 2025Terms

Trial snapshot

StatusRECRUITING

PhasePHASE2

Enrollment30

Start dateJan 2025

Last updatedFeb 10, 2025

Condition

Synucleinopathy Parkinson's Disease

Locations shown

Cedar Valley Digestive Health Center

Waterloo, Iowa

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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