Tenapanor in Synucleinopathy-Related Constipation

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Synucleinopathy, Parkinson's Disease

In brief

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

Key facts

Study ID

NCT06460038

Run by

Cedar Valley Digestive Health Center

People needed

30

Starts

2025-01-01

Expected to finish

2027-03-01

Last updated by the study team

2025-02-10

Who can join

Age: 50 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cedar Valley Digestive Health Center — Waterloo, Iowa, United States (enrolling)

Full record on ClinicalTrials.gov

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