Tenapanor in Synucleinopathy-Related Constipation

RecruitingPhase 2

Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation

Who can join

Ages 50 to 89 · All sexes

Full eligibility criteria

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.

About the study

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

What is being tested

Tenapanor (drug)
Placebo (drug)

Sponsor: Cedar Valley Digestive Health Center · Participants: 30 · Started: Jan 1, 2025

Contact the study team

Richard A. Manfready, MD, AM, FACP · Phone: (319) 235-5390
Harichandana Punukula, PharmD, MS · Phone: 319-888-8270

Official record on ClinicalTrials.gov — NCT06460038

Locations in the U.S.

Iowa	Cedar Valley Digestive Health Center, Waterloo

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.