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Tenapanor in Synucleinopathy-Related Constipation

RECRUITINGPhase 2Sponsored by Cedar Valley Digestive Health Center
Actively Recruiting
PhasePhase 2
SponsorCedar Valley Digestive Health Center
Started2025-01-01
Est. completion2026-12
Eligibility
Age50 Years – 89 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06460038

Summary

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

Eligibility

Age: 50 Years – 89 YearsHealthy volunteers accepted
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.

Conditions2

Parkinson's DiseaseSynucleinopathy

Locations1 site

Cedar Valley Digestive Health Center
Waterloo, Iowa, 50701
Harichandana Punukula, PharmD, MS319-888-8275hpunukula@cvmspc.com

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