Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation
Cedar Valley Digestive Health Center
Summary
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
- Age range
- 50–89 years
- Sex
- All
- Healthy volunteers
- No
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 Crit…
Interventions
- DrugTenapanor
Inhibitor of NHE3
- DrugPlacebo
Placebo drug
Location
- Cedar Valley Digestive Health CenterWaterloo, Iowa