Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06460038

Tenapanor in Synucleinopathy-Related Constipation

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Synucleinopathy Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Constipation Metabolic Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Parkinson Disease Parkinson's Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Signs and Symptoms Signs and Symptoms, Digestive Synucleinopathies

Age range

50 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cedar Valley Digestive Health Center

Waterloo, Iowa, 50701, United States

Location status: Recruiting

Location contact

Harichandana Punukula, PharmD, MS

CONTACT

[email protected]

319-888-8275

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Tenapanor

Drug

Inhibitor of NHE3

Placebo

Drug

Placebo drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. Calprotectin

    Time frame: Week 12

    Decrease in fecal calprotectin by 20% or greater

  3. Lipopolysaccharide binding protein

    Time frame: Week 12

    Decrease in serum lipopolysaccharide binding protein by 20% compared to baseline

  4. 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

  5. Plasma zonulin

    Time frame: Week 12

    Decrease in zonulin by 20% compared to baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Harichandana Punukula, PharmD, MS

CONTACT

[email protected]

319-888-8270

Richard A. Manfready, MD, AM, FACP

CONTACT

[email protected]

(319) 235-5390

Sponsors and collaborators

Lead sponsor

Cedar Valley Digestive Health Center

Other

Collaborators

  • Ardelyx

Registry information

Official study title

Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 14, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.