Tenapanor in Synucleinopathy-Related Constipation

Phase 2RecruitingNCT06460038

Cedar Valley Digestive Health Center30 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Synucleinopathy Parkinson's Disease

Interventions

TenapanorDRUG

Inhibitor of NHE3

PlaceboDRUG

Placebo drug

Eligibility

Sex: ALLMin age: 50 YearsMax age: 89 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cedar Valley Digestive Health Center

Waterloo, Iowa, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 6 of 12 weeks

Secondary Outcomes

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)

Time frame: 6 of 12 weeks

Calprotectin

Decrease in fecal calprotectin by 20% or greater

Time frame: Week 12

Lipopolysaccharide binding protein

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

Time frame: 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

Time frame: Week 12

Plasma zonulin

Decrease in zonulin by 20% compared to baseline

Time frame: Week 12

Central 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

Data from ClinicalTrials.gov

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