Recruiting
Phase 2

Tenapanor

Sponsor:

Cedar Valley Digestive Health Center

Code:

NCT06460038

Conditions

Synucleinopathy

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Tenapanor

Placebo

Study Details

Brief summary:

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

Conditions

Synucleinopathy

Parkinson's Disease

Study ID

NCT06460038

Start date

Jan 1, 2025

Status verified date

Feb, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tenapanor

Tenapanor 50 mg orally twice daily for 12 weeks

placebo comparator: Placebo

Placebo orally twice daily for 12 weeks

Interventions

Tenapanor

Inhibitor of NHE3

Placebo

Placebo drug

Primary outcome measure

  • Complete spontaneous bowel movements (CSBM) [ Time Frame: 6 of 12 weeks ]

Central Contacts and Locations

Central contacts

Richard A. Manfready, MD, AM, FACP

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

Harichandana Punukula, PharmD, MS

319-888-8270hpunukula@cvmspc.com

Locations

Cedar Valley Digestive Health Center

Recruiting

Waterloo, Iowa, United States, 50701

Contacts

Harichandana Punukula, PharmD, MS

319-888-8275hpunukula@cvmspc.com

More Information

Sponsor

Cedar Valley Digestive Health Center

Last update posted

Feb 10, 2025

Last verified

Feb, 2025

Keywords

  • tenapanor
  • synucleinopathy
  • Parkinson's disease
  • constipation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Cedar Valley Digestive Health Center on 2025-02-10.