Tenapanor in Synucleinopathy-Related Constipation

Launched by CEDAR VALLEY DIGESTIVE HEALTH CENTER · Jun 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tenapanor to see if it can help people with Parkinson's Disease who are experiencing constipation. Constipation is a common issue for those with this condition, and the trial aims to find an effective treatment. The researchers are currently looking for participants aged 50 to 89 years who have been diagnosed with Parkinson's Disease and have specific bowel movement issues, such as having fewer than six bowel movements a week.

If you or someone you know is interested in participating, it’s important to know that certain conditions must be met. For example, potential participants should not have other serious gastrointestinal problems or significant liver or kidney issues. During the trial, participants will likely be monitored closely to assess how well tenapanor works for relieving constipation. Overall, this study could lead to better treatment options for those facing constipation due to Parkinson's Disease.

Gender

ALL

Eligibility 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.