Tenapanor in Synucleinopathy-Related Constipation

Last updated: February 6, 2025
Sponsor: Cedar Valley Digestive Health Center
Overall Status: Active - Recruiting

Phase

2

Condition

Parkinson's Disease

Dyskinesias

Constipation

Treatment

Tenapanor

Placebo

Clinical Study ID

NCT06460038
2405-21279
  • Ages 50-89
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Tenapanor
Phase: 2
Study Start date:
January 01, 2025
Estimated Completion Date:
March 31, 2027

Study Description

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

Connect with a study center

  • Cedar Valley Digestive Health Center

    Waterloo, Iowa 50701
    United States

    Active - Recruiting

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