Tenapanor in Synucleinopathy-Related Constipation

Recruiting · NCT06460038 · Interventional (participants receive a specific treatment) · Lead sponsor: Cedar Valley Digestive Health Center

Interventions studied

PlaceboTenapanor

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

Age range

50 Years to 89 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 2

Study type

Interventional (participants receive a specific treatment)

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.

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.

1 location listed across 1 US state.