Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 89
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Cedar Valley Digestive Health Center · Other
Who this trial is looking for
This trial is looking for individuals who have Parkinson's disease and experience constipation. Participants will need to meet certain health criteria and will be monitored for their bowel habits during the study.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 50 and 89 years old.
I have been diagnosed with Parkinson's disease.
I have 5 or fewer bowel movements per week.
I have 2 or fewer complete bowel movements per week.
I have stool that is soft or hard (score of 3 or lower on the Bristol Stool Form Scale).
I agree to use contraception if needed.
You may not be able to join if
I have functional diarrhea or IBS-D.
I have significant gastrointestinal issues or inflammatory bowel disease.
I have serious liver or kidney problems.
I am pregnant or breastfeeding.
I have been diagnosed with primary dyssynergic defecation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation
Trial Locations
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Eligibility 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 mov…
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.
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