Tenapanor in Synucleinopathy-Related Constipation

Phase 2

Recruiting

• Conditions: Synucleinopathy; Parkinson's Disease
• Interventions: Drug: Tenapanor; Drug: Placebo

• Registration Number: NCT06460038
• Lead Sponsor: Cedar Valley Digestive Health Center

Brief Summary

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 Timeline

• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-14
• Study Start: 2025-01-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-12
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenapanor	Tenapanor	Tenapanor 50 mg orally twice daily for 12 weeks
Placebo	Placebo	Placebo orally twice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Complete spontaneous bowel movements (CSBM)	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 Outcome Measures

Name	Time	Method
Abdominal pain and bloating response	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)
Lipopolysaccharide binding protein	Week 12	Decrease in serum lipopolysaccharide binding protein by 20% compared to baseline
Calprotectin	Week 12	Decrease in fecal calprotectin by 20% or greater
Plasma zonulin	Week 12	Decrease in zonulin by 20% compared to baseline
Complete spontaneous bowel movements (CSBM) continuous	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

Trial Locations

Locations (1)

Cedar Valley Digestive Health Center; 🇺🇸 Waterloo, Iowa, United States