NCT06460038RecruitingPhase 2
Tenapanor in Synucleinopathy-Related Constipation
Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation
Source: ClinicalTrials.gov · Last updated 10 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 11 Jun 2024
- Start date
- 1 Jan 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Cedar Valley Digestive Health Center
- Diseases
- Parkinson disease
- NCT number
- NCT06460038
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 1 Jan 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Symptomatic structural GI abnormalities or inflammatory bowel disease.
Lab values
- Significant hepatic (ALT or AST ≥ 2.5x the upper limit of normal) or renal (serum creatinine \>2mg/dl) dysfunction.
Other
- Functional diarrhea or IBS-D/M based on Rome IV Criteria.
- Pregnancy or lactation.
- Diagnosis of primary dyssynergic defecation by anorectal manometry.
Who the study is looking for
- 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.
- Agreement to use contraception, if applicable.
Age in the registry: 50 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cedar Valley Digestive Health Center Coordinator of this site? Confirm its status | Waterloo | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.