NCT06460038
Tenapanor in Synucleinopathy-Related Constipation
Recruiting · Phase 2 · Cedar Valley Digestive Health Center · registry updated 2025-02-10
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation
Inclusion
- 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.
Exclusion
- 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.