Tenapanor for Parkinson's (NCT06460038)
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
Summary For Families
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 1 year and 11 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.