Treatment for constipation related to Parkinson's disease
Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation
This study is testing if a new medication called tenapanor can help people with Parkinson's disease who have constipation feel better by improving their bowel movements.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 50 Years to 89 Years |
| Sex | All |
| Sponsor | Cedar Valley Digestive Health Center Academic / other |
| Locations | 1 site (Waterloo, Iowa) |
| Trial ID | NCT06460038 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of tenapanor, a medication, in treating constipation associated with synucleinopathy in patients with Parkinson's disease. It is a randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive either tenapanor or a placebo without knowing which one they are receiving. The study aims to assess changes in bowel movement frequency and stool consistency over a specified period. Participants will undergo a screening process to confirm eligibility based on their bowel movement patterns and overall health.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50-89 with a diagnosis of Parkinson's disease in early to moderate stages and experiencing specific constipation symptoms.
Not a fit: Patients with functional diarrhea, inflammatory bowel disease, or significant liver or kidney dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve bowel function and quality of life for patients suffering from constipation due to Parkinson's disease.
How similar studies have performed: While this approach is novel in the context of synucleinopathy-related constipation, similar studies have shown promise in treating constipation with other interventions.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Waterloo, Iowa
- Cedar Valley Digestive Health Center — Waterloo, Iowa, United States (Recruiting)
Study contacts
- Principal investigator: Richard A. Manfready, MD, AM, FACP — Cedar Valley Digestive Health Center
- Study coordinator: Richard A. Manfready, MD, AM, FACP
- Email: rman@alum.mit.edu
- Phone: (319) 235-5390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.