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NCT06460038 | RECRUITING | Synucleinopathy

Tenapanor in Synucleinopathy-Related Constipation
Sponsor:

Cedar Valley Digestive Health Center

Brief Summary:

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

Condition or disease

Synucleinopathy

Parkinson's Disease

Intervention/treatment

Tenapanor

Placebo

Phase

PHASE2

Detailed Description:

Randomized, double-blind, placebo controlled trial of tenapanor vs. placebo for treating synucleinopathy-associated constipation in Parkinson\'s disease.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation
Actual Study Start Date : 2025-01-01
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2027-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 89 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
    • Tenapanor in Synucleinopathy-Related Constipation

    Location Details

    NCT06460038

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    How to Participate

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    Locations

    RECRUITING

    United States, Iowa

    Cedar Valley Digestive Health Center

    Waterloo, Iowa, United States, 50701