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?
- 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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.