Treatment for constipation related to Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of tenapanor, a medication, in treating constipation associated with synucleinopathy in patients with Parkinson's disease. It is a randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive either tenapanor or a placebo without knowing which one they are receiving. The study aims to assess changes in bowel movement frequency and stool consistency over a specified period. Participants will undergo a screening process to confirm eligibility based on their bowel movement patterns and overall health.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cedar Valley Digestive Health Center
  Waterloo, Iowa, United States Recruiting

Study contacts

• Principal investigator: Richard A. Manfready, MD, AM, FACP — Cedar Valley Digestive Health Center
• Study coordinator: Richard A. Manfready, MD, AM, FACP
• Email: rman@alum.mit.edu
• Phone: (319) 235-5390

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.