A Phase 2 interventional study of Tenapanor and Placebo in Synucleinopathy and Parkinson's Disease, sponsored by Cedar Valley Digestive Health Center. Recruiting at 1 site in United States. Open to participants aged 50 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Cedar Valley Digestive Health Center · Phase 2, Interventional, and Treatment
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation
Randomized, double-blind, placebo controlled trial of tenapanor vs. placebo for treating synucleinopathy-associated constipation in Parkinson\'s disease.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →This is the only study on the registry with Cedar Valley Digestive Health Center as lead sponsor.
Compared within Parkinson Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Synucleinopathies. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tenapanor 50 mg orally twice daily for 12 weeks
Drug: Tenapanor
Placebo orally twice daily for 12 weeks
Drug: Placebo
Inhibitor of NHE3
Placebo drug
Complete spontaneous bowel movements (CSBM)
Our primary endpoint will be CSBM response, defined as an increase of at least one CSBM per week compared to baseline for at least 6 of the 12 treatment weeks. A CSBM is defined as a bowel movement that occurs naturally and is accompanied by a feeling of complete evacuation
Time frame: 6 of 12 weeks
Abdominal pain and bloating response
Decrease in severity score of at least 20% or more from baseline in 6 of 12 weeks (pain visual analog scale 1-10 where 10 is worst pain)
Time frame: 6 of 12 weeks
Calprotectin
Decrease in fecal calprotectin by 20% or greater
Time frame: Week 12
Lipopolysaccharide binding protein
Decrease in serum lipopolysaccharide binding protein by 20% compared to baseline
Time frame: Week 12
Complete spontaneous bowel movements (CSBM) continuous
CSBM treated as a continuous variable. The investigators expect an increase of CSBMs in the treatment group compared to the placebo group. A CSBM is defined as a bowel movement that occurs naturally and is accompanied by a feeling of complete evacuation
Time frame: Week 12
Plasma zonulin
Decrease in zonulin by 20% compared to baseline
Time frame: Week 12
Plan to share: Yes — De-identified participant data
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 24 months. Data will be available upon request for 2 years following study publication.
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Data sharing details ↗ · library.rush.edu
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Studies of the drug tested here: Tenapanor