Tenapanor in Synucleinopathy-Related Constipation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-89
SponsorCedar Valley Digestive Health Center
About this trial
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation
Eligibility criteria
Qualifiers
Age 50-89 years.
Diagnosis of PD within Hoehn and Yahr stages 1-3, confirmed by a neurologist per International Parkinson and Movement Disorder Society criteria.
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.
Stool consistency ≤3 on the Bristol Stool Form Scale (BSFS). This criterion will be verified during a 2-week screening period.
Disqualifiers
Functional diarrhea or IBS-D/M based on Rome IV Criteria.
Symptomatic structural GI abnormalities or inflammatory bowel disease.
Significant hepatic (ALT or AST ≥ 2.5x the upper limit of normal) or renal (serum creatinine >2mg/dl) dysfunction.
Pregnancy or lactation.
Trial design
Treatments tested in this trial
- Tenapanor
- Placebo
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Cedar Valley Digestive Health Center
Lead sponsor
Ardelyx
Collaborator
Source ClinicalTrials.gov