RECRUITINGPhase 2INTERVENTIONAL
Tenapanor in Synucleinopathy-Related Constipation
Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation
About This Trial
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation
Who May Be Eligible (Plain English)
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Tenapanor
Inhibitor of NHE3
DRUG
Placebo
Placebo drug
Locations (1)
Cedar Valley Digestive Health Center
Waterloo, Iowa, United States