Overview
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation
Description
Randomized, double-blind, placebo controlled trial of tenapanor vs. placebo for treating synucleinopathy-associated constipation in Parkinson's disease.
Eligibility
Inclusion Criteria
- 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 Criteria
- 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.