Test tenapanor for Parkinson constipation
- Trial ID
- NCT06460038
- Official Title
- Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation
- Goal
- Test tenapanor for Parkinson constipation
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Cedar Valley Digestive Health Center
- Study Type
- INTERVENTIONAL
- Enrollment
- 30 participants
- Conditions
- Synucleinopathy, Parkinson's Disease
- Interventions
- Tenapanor, Placebo
Plain-Language Summary
The goal is to see if tenapanor can safely increase bowel movements and soften stools to relieve the chronic constipation many people with synucleinopathies like Parkinson's experience. The pill blocks the intestinal NHE3 sodium/hydrogen exchanger on gut lining cells, so less sodium is absorbed and more water stays in the bowel to soften stool and boost spontaneous bowel movements, and because it acts mainly in the gut with minimal systemic absorption it is not expected to interfere with levodopa. The trial is enrolling people 50 to 89 years old with Parkinson's at Hoehn and Yahr stages 1,3 who have chronic constipation verified during a 2-week screening (≤5 spontaneous BMs and ≤2 complete spontaneous BMs per week, Bristol stool form ≤3); those with IBS-D, structural GI disease, significant liver or kidney problems, pregnancy, or primary dyssynergic defecation are excluded.
Locations
- Cedar Valley Digestive Health Center, Waterloo, Iowa, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Tenapanor. The goal is to see if tenapanor can safely increase bowel movements and soften stools to relieve the chronic constipation many people with synucleinopathies like Parkinson's experience. The pill blocks the intestinal NHE3 sodium/hydrogen exchanger on gut lining cells, so less sodium is absorbed and more water stays in the bowel to soften stool and boost spontaneous bowel movements, and because it acts mainly in the gut with minimal systemic absorption it is not expected to interfere with levodopa. The trial is enrolling people 50 to 89 years old with Parkinson's at Hoehn and Yahr stages 1,3 who have chronic constipation verified during a 2-week screening (≤5 spontaneous BMs and ≤2 complete spontaneous BMs per week, Bristol stool form ≤3); those with IBS-D, structural GI disease, significant liver or kidney problems, pregnancy, or primary dyssynergic defecation are excluded.
- Who can participate?
- Participants must be between 50 Years and 89 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 1 year and 11 months.