NCT06460038PHASE2Recruiting
Tenapanor in Synucleinopathy-Related Constipation
Cedar Valley Digestive Health Center
Start Date
1/1/2025
Completion Date
3/1/2027
Summary
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation
Detailed Description
Randomized, double-blind, placebo controlled trial of tenapanor vs. placebo for treating synucleinopathy-associated constipation in Parkinson\'s disease.
Eligibility Criteria
Age Range: 50 years to 89 years
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.
Interventions
DRUG
Tenapanor
DRUG
Placebo
Conditions
SynucleinopathyParkinson's Disease
Locations
Cedar Valley Digestive Health Center
Waterloo, Iowa 50701
United States